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FDA Approves Booster Dose for Teens – Medical Products Supply Chain Weekly Review | Alston & Bird

During the holidays, the CDC updated its recommendations for quarantine and post-exposure masking. The FDA has cleared the booster dose of Pfizer vaccine for adolescents 12 to 15 years old and for immunocompromised children 5 to 11 years old. The FDA has released draft guidelines for manufacturers of medical devices marketed under EUA or enforcement discretion policies to help them transition to traditional approvals at the end of the health emergency. public. The Administration has convened the Supply Chain Disruption Working Group for an update on its progress. The FDA has issued guidance for lab staff and manufacturers on technical considerations for new strains in developing COVID-19 tests and reading current test results. Please see details of these and other supply chain developments below:

  • On December 22, the President convened a meeting of the Supply Chain Disruption Task Force with stakeholders from the business sector. The implementation of the recommendations of the Working Group has led to drastic improvements in the flow of goods in the main ports. Dwell times in the ports of Long Beach and Los Angeles have been reduced from 12 to 5 days and from 9 to 4 days, respectively. The Port of Savannah with the Georgia Ports Authority has set up inland pop-up container sites that are accessible by truck and train, speeding up the movement of containers to these locations. The involvement of commercial carriers has also accelerated the movement of goods through the supply chain. The ports of Long Beach and Los Angeles are still operating towards 24/7 operation.
  • On December 22, administration officials met with EU officials on COVID-19 and global health security to assess each country’s progress towards the goal of the partnership cemented in September to defeat the global pandemic . Increasing the global production of vaccines and supplies is a major component of the initiative. The meeting also focused on developing strategies for future actions, including establishing a source of funding for such efforts.
  • On December 22, the FDA Center for Device and Radiological Health (CDRH) released a draft guidance document “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUA) During Coronavirus Disease 2019 (COVID-19) Public health emergency ”and“ Transition plan for medical devices that fall under enforcement policies during the public health emergency of coronavirus disease 2019 (COVID-19). These proposed transition plans are guided by the principles of ensuring continued access of patients, providers and consumers to quality products; adequately prepare manufacturers and other stakeholders for the transition; and avoid supply chain disruptions. The plans would provide guidance on the requirements and timelines for marketing presentations. Assessment methods would include a risk-based approach that takes into account the intended uses, regulatory history and the level of risk of the device. A notice will be published for manufacturers 180 days before the expiration date of the EUA declaration. An EUA declaration is separate from a public health emergency declaration. Once an EUA declaration is terminated, all EUAs authorized under the EUA declaration are also terminated. Manufacturers must notify the FDA if they intend to continue marketing their products. The FDA intends to apply a phased approach to products marketed under discretionary enforcement policies that allow manufacturers to prepare for new requirements to avoid disruption. Comments on these draft guidelines are expected by March 23, 2022. We recommend that stakeholders carefully review the documents, submit comments if necessary, and start preparing for transitions early.
  • On December 22, the FDA released a draft guideline, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” to provide sponsors and other stakeholders with guidance on how to assess digital health technology (DHT) used in their clinical investigations. The draft guidance includes how to assess a DHT as suitable for use. When evaluating a product, sponsors and stakeholders should consider the rationale for using the product and its descriptions. Sponsors and stakeholders should also consider whether the product can offer verification, validation and usability information. In addition, investigators should determine whether DHT would provide data permitting an appropriate assessment of clinical parameters from the data from any statistical analysis. The draft guidance also emphasizes that risk considerations regarding clinical risks, confidentiality and informed consent should be considered. Comments are due by March 22, 2022.
  • On December 23, the FDA released a revised guideline, “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests,” which contains specific information regarding the omicron variant. The agency asks labs to be aware that some molecular tests fail to detect omicron and that there are other tests that detect modified omicron. Tests that do not detect omicron should not be used. Laboratories that use tests with multiple genetic targets should be aware that omicron demonstrates genetic abandonment in the results. Although this result may indicate the presence of omicron, it is not definitive. In light of this, the FDA advises labs to consider genetic sequencing if available.
  • On December 27, the CDC announced that it was recommending a five-day window for isolation and the use of masks for asymptomatic people with positive COVID-19 results. The CDC has also changed its recommendations for people exposed to someone with COVID-19 in isolation with strict mask use for five days after exposure for those exposed who are not vaccinated or have been vaccinated more. six months previously (two months for Johnson & Johnson). For those who have received a booster, isolation is not required; however, the use of a mask for five days followed by a test on the fifth day is recommended.
  • On December 29, the Center for Devices and Radiological Health (CDRH) issued an EUA for CLINITEST, a rapid self-test of the COVID-19 antigen from Siemens. This EUA is particularly important because the validation data was collected through the FDA’s collaboration with the National Institutes of Health (ITAP) Independent Testing Assessment Program. SD Biosensor Inc. has also been granted EUA for its home COVID-19 test.
  • On January 3, the FDA announced changes to the EUA for the Pfizer vaccine. The agency decided to allow a booster dose for adolescents 12 to 15 years old and to shorten the recommended time between the primary vaccination and the booster dose to five months, instead of six months. The decision was made on the basis of actual data from Israel which showed no additional security concerns. The decision to reduce the time between the primary series and the booster is taken in response to the prevalence of the more transmissible omicron variant and the need to strengthen the immune response of the population. The FDA has also cleared a third dose of Pfizer vaccine for immunocompromised children 5 to 11 years old. The agency defines immunocompromised as those who have undergone a solid organ transplant or similar conditions that compromise their immune system. The aim is to strengthen their immune response to “enable these children to obtain the maximum potential benefit from the vaccination”.

[View source.]

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Medical products

FDA Cleared Booster Dose for Teens – Medical Products Supply Chain Weekly Review – Food, Drugs, Healthcare, Life Sciences

United States: FDA Approves Booster Dose for Teens – Medical Products Supply Chain Weekly Review

To print this article, simply register or connect to Mondaq.com.

During the holidays, the CDC updated its recommendations for quarantine and post-exposure masking. The FDA has cleared the booster dose of Pfizer vaccine for adolescents 12 to 15 years old and for immunocompromised children 5 to 11 years old. The FDA has released draft guidelines for manufacturers of medical devices marketed under EUA or enforcement discretion policies to help them transition to traditional approvals at the end of the health emergency. public. The Administration has convened the Supply Chain Disruption Working Group for an update on its progress. The FDA has issued guidance for lab staff and manufacturers on technical considerations for new strains in developing COVID-19 tests and reading current test results. Please see details of these and other supply chain developments below:

  • On December 22, the President convened a meeting of the Supply Chain Disruption Task Force with stakeholders from the business sector. The implementation of the recommendations of the Working Group has led to drastic improvements in the flow of goods in the main ports. Dwell times in the ports of Long Beach and Los Angeles have been reduced from 12 to 5 days and from 9 to 4 days, respectively. The Port of Savannah with the Georgia Ports Authority has set up inland pop-up container sites that are accessible by truck and train, speeding up the movement of containers to these locations. The involvement of commercial carriers has also accelerated the movement of goods through the supply chain. The ports of Long Beach and Los Angeles are still operating towards 24/7 operation.
  • On December 22, administration officials met with EU officials on COVID-19 and global health security to assess each country’s progress towards the goal of the partnership cemented in September to defeat the global pandemic . Increasing the global production of vaccines and supplies is a major component of the initiative. The meeting also focused on developing strategies for future actions, including establishing a source of funding for such efforts.
  • On December 22, the FDA Center for Device and Radiological Health (CDRH) released a draft guidance document “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUA) During Coronavirus Disease 2019 (COVID-19) Public health emergency ”and“ Transition plan for medical devices that fall under enforcement policies during the public health emergency of coronavirus disease 2019 (COVID-19). These proposed transition plans are guided by the principles of ensuring continued access of patients, providers and consumers to quality products; adequately prepare manufacturers and other stakeholders for the transition; and avoid supply chain disruptions. The plans would provide guidance on the requirements and timelines for marketing presentations. Assessment methods would include a risk-based approach that takes into account the intended uses, regulatory history and the level of risk of the device. A notice will be published for manufacturers 180 days before the expiration date of the EUA declaration. An EUA declaration is separate from a public health emergency declaration. Once an EUA declaration is terminated, all EUAs authorized under the EUA declaration are also terminated. Manufacturers must notify the FDA if they intend to continue marketing their products. The FDA intends to apply a phased approach to products marketed under discretionary enforcement policies that allow manufacturers to prepare for new requirements to avoid disruption. Comments on these draft guidelines are expected by March 23, 2022. We recommend that stakeholders carefully review the documents, submit comments if necessary, and start preparing for transitions early.
  • On December 22, the FDA released a draft guideline, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” to provide sponsors and other stakeholders with guidance on how to assess digital health technology (DHT) used in their clinical investigations. The draft guidance includes how to assess a DHT as suitable for use. When evaluating a product, sponsors and stakeholders should consider the rationale for using the product and its descriptions. Sponsors and stakeholders should also consider whether the product can offer verification, validation and usability information. In addition, investigators should determine whether DHT would provide data permitting an appropriate assessment of clinical parameters from the data from any statistical analysis. The draft guidance also emphasizes that risk considerations regarding clinical risks, confidentiality and informed consent should be considered. Comments are due by March 22, 2022.
  • On December 23, the FDA released a revised guideline, “SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests,” which contains specific information regarding the omicron variant. The agency asks labs to be aware that some molecular tests fail to detect omicron and that there are other tests that detect modified omicron. Tests that do not detect omicron should not be used. Laboratories that use tests with multiple genetic targets should be aware that omicron demonstrates genetic abandonment in the results. Although this result may indicate the presence of omicron, it is not definitive. In light of this, the FDA advises labs to consider genetic sequencing if available.
  • On December 27, the CDC announced that it was recommending a five-day window for isolation and the use of masks for asymptomatic people with positive COVID-19 results. The CDC has also changed its recommendations for people exposed to someone with COVID-19 in isolation with strict mask use for five days after exposure for those exposed who are not vaccinated or have been vaccinated more. six months previously (two months for Johnson & Johnson). For those who have received a booster, isolation is not required; however, the use of a mask for five days followed by a test on the fifth day is recommended.
  • On December 29, the Center for Devices and Radiological Health (CDRH) issued an EUA for CLINITEST, a rapid self-test of the COVID-19 antigen from Siemens. This EUA is particularly important because the validation data was collected through the FDA’s collaboration with the National Institutes of Health (ITAP) Independent Testing Assessment Program. SD Biosensor Inc. has also been granted EUA for its home COVID-19 test.
  • On January 3, the FDA announced changes to the EUA for the Pfizer vaccine. The agency decided to allow a booster dose for adolescents 12 to 15 years old and to shorten the recommended time between the primary vaccination and the booster dose to five months, instead of six months. The decision was made on the basis of actual data from Israel which showed no additional security concerns. The decision to reduce the time between the primary series and the booster is taken in response to the prevalence of the more transmissible omicron variant and the need to strengthen the immune response of the population. The FDA has also cleared a third dose of Pfizer vaccine for immunocompromised children 5 to 11 years old. The agency defines immunocompromised as those who have undergone a solid organ transplant or similar conditions that compromise their immune system. The aim is to strengthen their immune response to “enable these children to obtain the maximum potential benefit from the vaccination”.

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

POPULAR ARTICLES ON: Food, Medicines, Health Care, Life Sciences of the United States

Alston and Birds Health Care Week in Review, December 17, 2021

Alston & Bird

Below is Alston & Bird’s Healthcare Week review, which provides a summary of the latest healthcare regulatory news, advice and guidance; federal legislation and the work of congressional committees; reports, studies and analyzes; and other health policy news.

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Medical products

FDA clears two oral drugs for COVID-19 – Medical Products Supply Chain Weekly Review – Food, Drugs, Healthcare, Life Sciences

United States: FDA clears two oral drugs for COVID-19 – Medical products supply chain review of the week

To print this article, simply register or connect to Mondaq.com.

Last week, the FDA cleared oral antivirals from Pfizer and Merck for the treatment of COVID-19. The Biden-Harris administration released the trucking action plan. The CDC approved the ACIP preference recommendation for the Pfizer-BioNTech and Moderna vaccine boosts. The new recommended Tris vaccine buffer leads to greater stability and does not require dilution. Please see details of these and other supply chain developments below:

  • On December 15, the FDA approved Eagle Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for injection of vasopressin (20 units / ml in multidose vials), a product that has grown in demand during the COVID-pandemic. 19. The FDA said that this approval, the first approval from an ANDA for this product, represents the agency’s commitment “to facilitate access to medical products to help meet the critical needs of the American public.”
  • On December 16, the Authority released its Trucking Action Plan to help reduce supply chain disruption as part of initiatives promoted by the Chain Disruption Task Force. supply. Globally, the plan aims to implement measures to reduce barriers to the issuance of commercial driver’s licenses (CDLs); accelerate the learning of trucking; recruit veterans, especially those with previous trucking experience, into the industry; and schedule listening sessions with the current workforce to implement improvement strategies. In order to promote immediate implementation, the plan also includes specific actions for 30, 60 and 90 days to implement the objectives of the plan.
  • On December 16, the FDA approved the use of Tris buffer for the manufacture of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. This new formulation offers two key advantages to vaccinators: (1) it increases the stability of the vaccine longer at refrigerated temperatures; and (2) it does not require dilution by the supplier before use.
  • On December 16, the CDC approved the Advisory Committee on Immunization Practices (ACIP) recommendations that the Pfizer-BioNTech and Moderna vaccines are preferred for booster use over the Johnson & Johnson vaccine. ACIP met earlier today and based its decision on data including a review of efficacy and adverse events.
  • On December 17, the FDA announced that it was considering a program that would impose sterilization changes to the master file pilot program for 510 (k) approved medical devices. The change applies to the established Category B or to new sterilization methods. In addition to manufacturers in the innovation challenge, current 510 (k) holders can also participate in two previous programs where the FDA (1) has challenged manufacturers to develop new ways to develop alternatives to the ethylene oxide; and (2) reduce emissions of ethylene oxide. If changes are made to sterilization methods when ethylene oxide is used, participants can now refer to their master files instead of submitting a new 510 (k).
  • On December 20, Moderna announced that it was continuing to advance clinical trials to develop an omicron-specific vaccine for use as a booster. He also noted that the antibodies from his 50mcg and 100mcg booster doses demonstrated a 37- and 83-fold increase in antibody levels. Clinical trials of vaccines targeting both omicron and delta are underway.
  • On December 21, the Center for Devices and Radiological Health (CDRH) released a plan for how the CDRH intends to manage reviewer workload in 2022 based on the increase in the total number of submissions. In 2021, the CDRH saw an increase in medical device submissions for approval through the traditional processes, namely the PMA, 510 (k) and Q-sub processes, which it addressed through the implementation of new approaches to review, including triage of cases, reallocation of staff and resources to COVID-19 products, use of contractors and overtime. Despite these approaches, some issues related to meeting review deadlines still need to be addressed. For devices other than in vitro diagnostics, the CDRH expects to be able to comply with the review deadlines of the Medical Device User Fee Agreement (MDUFA) in 2022 despite the influx of medical products subject to review. For in vitro diagnostic products, the CDRH will also try to meet the deadlines promised by the MDUFA. Non-COVID products that were not prioritized during the pandemic will require extended review times. In addition, the pre-submission request program will be reinstated as of January 1, 2022.
  • On December 22, the FDA cleared Pfizer’s oral antiviral drug, Paxlovid, for the treatment of mild to moderate COVID-19 in adults and children 12 years of age or older (weighing 40 kg or more). This is the first oral antiviral treatment for COVID-19 to receive emergency use authorization. The clearance was based on data from the EPIC-HR trial, which demonstrated that Paxlovid significantly reduced hospitalizations and deaths from all causes in the study population compared to those randomized to receive a placebo. Paxlovid is a combination of nirmatrelvir and ritonavir – the former inhibits the replication of SARS-CoV-2 and the latter slows down the breakdown of nirmatrelvir in the body. The FDA will continue to monitor clinical trial data for the safety and effectiveness of the drug.
  • On December 23, the FDA cleared Merck’s oral antiviral drug, molnupiravir, for the treatment of mild to moderate COVID-19 in adults at high risk of progression to severe COVID-19 and for whom options for Alternative treatment to COVID-19 is not available. accessible or clinically appropriate.

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

POPULAR ARTICLES ON: Food, Medicines, Health Care, Life Sciences of the United States

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Medical products

FDA Approves Two Oral COVID-19 Drugs – Medical Products Supply Chain Weekly Review | Alston & Bird

Last week, the FDA cleared oral antivirals from Pfizer and Merck for the treatment of COVID-19. The Biden-Harris administration released the trucking action plan. The CDC approved the ACIP preference recommendation for the Pfizer-BioNTech and Moderna vaccine boosts. The new recommended Tris vaccine buffer leads to greater stability and does not require dilution. Please see details of these and other supply chain developments below:

  • On December 15, the FDA approved Eagle Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for injection of vasopressin (20 units / ml in multidose vials), a product that has grown in demand during the COVID-pandemic. 19. The FDA said that this approval – the first approval from an ANDA for this product – represents the agency’s commitment “to facilitate access to medical products to help meet the critical needs of the American public.”
  • On December 16, the Authority released its Trucking Action Plan to help reduce supply chain disruption as part of initiatives encouraged by the Chain Disruption Task Force. supply. Globally, the plan aims to implement measures to reduce barriers to the issuance of commercial driver’s licenses (CDLs); accelerate the learning of trucking; recruit veterans, especially those with previous trucking experience, into the industry; and schedule listening sessions with the current workforce to implement improvement strategies. In order to promote immediate implementation, the plan also includes specific actions for 30, 60 and 90 days to implement the objectives of the plan.
  • On December 16, the FDA approved the use of Tris buffer for the manufacture of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. This new formulation offers two key advantages to vaccinators: (1) it increases the stability of the vaccine longer at refrigerated temperatures; and (2) it does not require dilution by the supplier before use.
  • On December 16, the CDC approved the Advisory Committee on Immunization Practices (ACIP) recommendations that the Pfizer-BioNTech and Moderna vaccines are preferred for booster use over the Johnson & Johnson vaccine. ACIP met earlier today and based its decision on data including a review of efficacy and adverse events.
  • On December 17, the FDA announced that it was considering a program that would impose sterilization changes to the master file pilot program for 510 (k) approved medical devices. The change applies to the established Category B or to new sterilization methods. In addition to manufacturers in the innovation challenge, current 510 (k) holders can also participate in two previous programs where the FDA (1) has challenged manufacturers to develop new ways to develop alternatives to it. ethylene oxide; and (2) reduce emissions of ethylene oxide. If changes are made to sterilization methods when ethylene oxide is used, participants can now refer to their master files instead of submitting a new 510 (k).
  • On December 20, Moderna announced that it was continuing to advance clinical trials to develop an omicron-specific vaccine for use as a booster. He also noted that the antibodies from his 50mcg and 100mcg booster doses demonstrated a 37- and 83-fold increase in antibody levels. Clinical trials of vaccines targeting both omicron and delta are underway.
  • On December 21, the Center for Devices and Radiological Health (CDRH) released a plan for how the CDRH intends to manage reviewer workload in 2022 based on the increase in the total number of submissions. In 2021, the CDRH saw an increase in medical device submissions for approval through the traditional processes, namely the PMA, 510 (k) and Q-sub processes, which it addressed through the implementation of new approaches to review, including triage of cases, reallocation of staff and resources to COVID-19 products, use of contractors and overtime. Despite these approaches, some issues related to meeting review deadlines still need to be resolved. For devices other than in vitro diagnostics, the CDRH expects to be able to meet the review deadlines of the Medical Device User Fee Agreement (MDUFA) in 2022 despite the influx of medical products subject to review. For in vitro diagnostic products, the CDRH will also try to meet the deadlines promised by the MDUFA. Non-COVID products that were not prioritized during the pandemic will require extended review times. In addition, the pre-submission request program will be reinstated as of January 1, 2022.
  • On December 22, the FDA cleared Pfizer’s oral antiviral drug, Paxlovid, for the treatment of mild to moderate COVID-19 in adults and children 12 years of age or older (weighing 40 kg or more). This is the first oral antiviral treatment for COVID-19 to receive emergency use authorization. The clearance was based on data from the EPIC-HR trial, which demonstrated that Paxlovid significantly reduced hospitalizations and deaths from any cause in the study population compared to those randomized to receive a placebo. Paxlovid is a combination of nirmatrelvir and ritonavir – the former inhibits the replication of SARS-CoV-2 and the latter slows down the breakdown of nirmatrelvir in the body. The FDA will continue to monitor clinical trial data for the safety and effectiveness of the drug.
  • On December 23, the FDA cleared Merck’s oral antiviral drug, molnupiravir, for the treatment of mild to moderate COVID-19 in adults at high risk of progression to severe COVID-19 and for whom options for Alternative treatment to COVID-19 is not available. accessible or clinically appropriate.

[View source.]

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Medical products

Which medical products are at the top of Amazon’s listings?

What medical products are hot on Amazon this season? As expected, as the pandemic continues, thermometers and masks are on buyers’ lists, but so are perennial products such as relaxation and fitness items. Many articles are digital health products, demonstrating the trend of deepening consumption. And you may even see some similarities to articles from our previous look at Amazon buying trends.

On December 21, the top 10 gift ideas in home medical supplies and equipment were:

  • Fitbit Inspire 2 Health & Fitness Tracker with 1-Year Free Fitbit Premium Trial, 24/7 Heart Rate, Black / Black, One Size (S and L Bands Included)
  • Fitbit Charge 5 Advanced Fitness & Health Tracker with Built-in GPS, Stress Management Tools, Sleep Tracker, 24 Hour Heart Rate & Up, Black / Graphite, One Size (S and L Bands Included)
  • AncestryDNA: genetic ethnicity test, ethnicity estimate, AncestryDNA test kit
  • 23andMe Ancestry + Traits Service: Personal genetic DNA testing with over 2000 geographic regions, family tree, relative DNA research, and trait reports
  • Fitbit Luxe Fitness and Wellness Tracker with Stress Management, 24/7 Sleep and Heart Rate Tracker, Black / Graphite, One Size (S and L Bands Included)
  • AncestryDNA + Traits: Genetic Ethnicity Test + Traits, AncestryDNA Test Kit with 35+ Traits, DNA Ancestry Test Kit, Genetic Test Kit
  • Black Disposable Masks 50PCS 3 Ply Breathable Filter Protection
  • KardiaMobile Single Lead Personal ECG Monitor | FDA Approved | Detects AFib
  • IHealth No-Touch forehead thermometer, digital infrared thermometer for adults and children, non-contact baby thermometer with 3 ultra-sensitive sensors, large LED display and soft vibration alert (PT3)
  • RENPHO Body Fat Scale Smart BMI Scale Wireless Digital Bathroom Weight Scale Body Composition Analyzer with Sync Smartphone App with Bluetooth 396 lbs – Black

Also on December 21, the top 10 most wanted home medical supplies and equipment were:

  • IHealth No-Touch forehead thermometer, digital infrared thermometer for adults and children, non-contact baby thermometer with 3 ultra-sensitive sensors, large LED display and soft vibration alert (PT3)
  • FYY Daily Pill Organizer, 7 Compartment Portable Travel Pill Organizer, [Folding Design] Pocket Purse Pill Box Holds Vitamins, Cod Liver Oil, Supplements & Medication – Blue
  • Elviros Memory Foam Neck Pillow, Contour Pillows for Neck and Shoulder Pain, Ergonomic Orthopedic Neck Support Pillow for Side, Back and Tummy Sleep (Blue-S)
  • Avana Kind Bed Orthopedic Support Wedge Pillow Comfort System, Blue / Gray
  • FridaBaby Fast Read Digital Rectal Thermometer
  • Neck and Shoulder Relaxer, Cervical Traction Device for TMJ Pain Relief and Cervical Spine Alignment, Chiropractic Neck Stretcher (Blue)
  • RENPHO Body Fat Scale Smart BMI Scale Wireless Digital Bathroom Weight Scale Body Composition Analyzer with Sync Smartphone App with Bluetooth 396 lbs – Black
  • Fitbit Inspire 2 Health & Fitness Tracker with 1-Year Free Fitbit Premium Trial, 24/7 Heart Rate, Black / Black, One Size (S and L Bands Included)
  • 23andMe Health + Ancestry Service: Personal genetic DNA testing, including health predispositions, carrier status, well-being, and trait reports (before purchasing, see important test information below below)
  • Non-contact forehead thermometer for adults and children, home digital infrared thermometer with fever indicator, instant accurate reading

And the top 10 sellers in home medical supplies and equipment on December 21 were:

  • Black Disposable Masks 50PCS 3 Ply Breathable Filter Protection
  • Zacurate Pro Series 500DL Fingertip Pulse Oximeter Blood Oxygen Saturation Monitor with Silicone Cover, Batteries and Lanyard (Royal Black)
  • Disposable face mask, black masks, 3-ply disposable face mask (200 pieces, black)
  • ApePal KN95 5-Layer Disposable Face Masks, Wide Elastic Earrings, Safety Face Mask, Black, 50 Pieces / Pack
  • Non-contact forehead thermometer for adults and children, home digital infrared thermometer with fever indicator, instant accurate reading
  • 100pcs Black Disposable Masks For Adults 3 Layer Non Woven Masks With Soft Elastic Earring
  • Wecolor 50 Disposable 3-Ply Earring Masks, Suitable for Home, School, Office and Outdoor (Black)
  • Black Face Mask 100pcs Disposable Masks Breathable 3-Layer Masks Mouth Cover for Adult Men and Women
  • 100pcs Black Disposable Face Mask 3 Ply Filter Protection Non-medical Face Masks Face Cover
  • Black disposable face masks, 3 ply face masks of 50 disposable masks

The listings above are only a snapshot taken on December 21, so be sure to click on the links for up-to-date rankings.

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FTC to Survey Big Business Supply Chain Problems – Medical Products Supply Chain Weekly Review | Alston & Bird

Over the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on problems and solutions in their supply chain. The FDA has issued an Emergency Use Clearance (EUA) for monoclonal therapy to include all children. An independent survey of pharmacies indicates that they still face supply chain issues. Please see details of these and other supply chain developments below:

  • On November 29, the FTC ordered nine major U.S. companies to provide the government with information about their supply chain operations. Specifically, the FTC is conducting an investigation to determine the reason for the delays. The FTC has asked companies to provide information on the main drivers of disruption in their supply chain and what they have done to address the issues. Companies have 45 days to respond.
  • On November 30, the FDA released a statement that discusses its omicron variant surveillance plan. The plan includes ongoing reporting by stakeholders of the impact of the variant on testing, vaccines and treatments. Currently, the FDA expects the variant to have a low impact on testing capabilities and infrastructure. The information will be released to the public as soon as it becomes available.
  • On December 3, the FDA expanded the EUA for two monoclonal antibodies – bamlanivimab and etesevimab (used in combination) – to include treatment of all pediatric patients, including newborns, who test positive for the COVID test -19 and are at high risk of progression to severe COVID-19. The combination drug is now also authorized for post-exposure prophylaxis for the prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19. The move comes after the FDA evaluated the results of clinical trials that showed the therapy to be safe and effective.
  • On December 3, the Federal Reserve released a note based on a textual analysis of earnings calls to account for the effects of the supply chain bottleneck on prices. Call SMS messages won from the S&P Global Market Intelligence database were searched for certain terms and were classified as positive impact or negative impact. Additionally, the authors used a regression model to analyze the impact of supply bottlenecks on concerns. The authors’ findings suggest that the global container shortage is the primary concern of most industries, and that the automotive sector suffers the most negative impacts. In an analysis of companies facing large supply chain disruptions versus low disruptions, those that experienced large disruption experienced statistically significant price increases. Overall, stronger global demand, supply bottlenecks and chip shortages had the biggest effect on prices. It is important to note that capacity issues and shipping bottlenecks have not resulted in price increases due to the increase in mentions in calls.
  • On December 8, the FDA issued an EUA for AstraZeneca’s Evusheld, an injectable drug combined with monoclonal antibodies. The authorization is for use in adults and adolescents 12 years of age and older who also have moderately to severely compromised immune systems or whose vaccination is not recommended due to serious side effects. Data from a clinical trial have shown a 77% reduction in the risk of contracting COVID-19 after treatment, with efficacy lasting up to six months.
  • On December 8, the FDA released a draft guideline titled “Considerations for Using Real Data and Evidence to Support Regulatory Decision Making for Drugs and Biologics”. The goal of the guidance, which would meet a mandate under the 21st Century Cures Act of 2016, is to facilitate increased efficiency in the approval of new indications for legally marketed drugs. Sponsors are encouraged to contact the FDA to discuss their draft study protocol and statistical analysis plan for review and comment before finalizing the documents. Additionally, sponsors need to consider and address data privacy concerns using real world data.
  • On December 9, the Treasury Department’s Office of Foreign Assets Control (OFAC) imposed sanctions on foreign government officials and entities on the International Anti-Corruption Day. The initiative targets, among others, heads of state and entities that have participated in acts of corruption in the context of “COVID-19 purchases”. Specifically, officials who have engaged in bribery programs, inflation in the prices of medical devices and PPE, and improper awarding of contracts are subject to sanctions. Government officials and their families have also faced sanctions for US visas.
  • On December 9, at the Food and Drug Law Institute’s Enforcement, Litigation and Compliance conference, Elizabeth Miller of the FDA, deputy commissioner for medical products and tobacco operations in the Office of Regulatory Affairs, spoke revealed that the agency is planning a pilot program to conduct unannounced inspections in India and expand the program to China.
  • On December 10, the Department of Transportation announced that the agency had awarded $ 12.6 million in America’s Marine Highway (AMHP) grants to nine maritime highways to help deal with disruption in the water supply chain. supply and movement of goods. AMHP, which operates as a public-private partnership, seeks to reduce land congestion, support transport options and improve the performance of the transport system. Some specific projects mentioned include funding for a New York / New Jersey barge project to increase trailer transportation, increasing the operational capacity of the Richmond, Virginia marine terminal, and upgrading ship equipment. a marine terminal in North Carolina.
  • On December 10, the Center for Devices and Radiological Health released a discussion paper titled “Point-of-Care 3D Printing of Medical Devices.” The paper provides background, an overview of how these devices might be approved for point-of-care use, and the challenges of this approach. The authors also ask 16 questions on which they would like to receive comments. Public comments are expected on February 8, 2022.
  • On December 16, the FDA released a draft guideline, “Inspection of Injectables for Visible Particles: Draft Guidance for Industry.” The guidelines aim to provide industry with risk-based procedures to “assess, correct and prevent the risk of visible particulate contamination”. Serious adverse events have been observed following injectables contaminated with visible particles. Manufacturers performing risk assessments and implementing mitigation strategies for injectables containing visible particles should consider the type of particles, container components and closure systems, and quality assurance procedures, among other factors. Comments are due by February 14, 2022.
  • The International Coalition of Drug Regulators has published an article from its COVID-19 Working Group, “Remote PCB and GMP Regulatory Oversight Inspections”. The document provides an assessment of how regulators provided remote monitoring during the pandemic, the challenges of implementation, and the success of the programs. The Working Group noted that while the possibilities offered by remote monitoring facilitate new monitoring methods, they should not replace traditional inspections. However, there is room for supplementation with these new tools.
  • The National Community Pharmacists Association has released the results of a survey showing that supply chain issues continue to plague 60% of independent pharmacies. In addition to these disruptions, independent pharmacies continue to flag staff, low reimbursement rates and market forces as reasons for their concern. Supply chain disruptions have increased consumer wait times for prescriptions. Overall, 41% of respondents felt that the state of the industry can be classified from bad to very bad.
  • Amazon has invested in a private supply chain network that has helped the company bypass supply chain issues. The company uses charter freighters, its own shipping containers, ships that bypass the busiest ports of Los Angeles and Long Beach, and planes that bypass ports completely. By serving as its own shipping provider, Amazon can use less busy ports for deliveries and is not dependent on container availability and access by third-party shipping companies. Amazon is now estimated to ship 72% of its merchandise. In addition, Amazon has increased the number of vacation rentals by 50% and increased the number of new installations.

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Medical products

Museveni supports planned medical products factory

President Yoweri Museveni welcomes the initiative being considered by a local company Microhaem Scientific and Medical Supplies Limited and its partners to establish a medical diagnostics and pharmaceutical factory in the country.

During his meeting with a delegation from Microhaem Scientifics (MHS) and its business partners on Thursday, December 9 at State House Nakasero, the president assured the group that he was ready to support initiatives to produce diagnostic tools. and human medicines locally in the country. He said such facilities would also benefit regional and continental demand for medicines for human use.

“I should support the partnership. I tell you that there is a huge demand for human drugs in the country, the region and beyond. The demand is not just in Uganda, the issue affects the entire East African region and the continent. It is not only a question of manufacturing but also of answering the question of the strong demand ”, declared President Museveni.

The president observed that the government spends large sums of money to buy human drugs and diagnostic tools abroad. He further noted that by looking at the annual imports into the country, the import of drugs is very large and continues to expand.

Mr Museveni suggested to investors in the planned partnership that if they chose to manufacture drugs in the country, they would be supported by the indigenous raw materials available to master the manufacturing process. He cited the presence of cinchona which was originally found in South America and which is used in the manufacture of quinine, an antimalarial drug.

“Here in Uganda we have many such products which can be obtained from the local green vegetation. If the pharmaceutical manufacturers have the diverse knowledge to manufacture a variety of medical products, it would be much better for the country and for them. [investors] being insured with the market, ” he added.

MHS Head of Delegation and Managing Director Cedric Akwesigye, who led the discussion, pointed out that Microhaem Scientifics Supplies Ltd (MHS), a Ugandan company founded in 2012, is a huge investment aimed at solving the problem. problem of lack of technical support. on medical equipment and the quality of medical supplies in the country.

“In record time, MHS has partnered with government to set up well-established medical laboratories for the Uganda Virus Research Institute (UVRI) and Central Public Health Laboratories (CPHL) at border points from Malaba, Elegu, Mutukula. These labs have dramatically reduced the turnaround time for COVID-19 test results, especially for truck drivers. So far, the company’s medical facilitation capacity has supported 500,000 Covid-19 tests, ”he said.

Mr. Akwesigye also noted that the president’s stewardship has championed the growth of local businesses like MHS to achieve partnership milestones with reputable global companies. He pledged MHS ‘continued strategic investment in addressing the medical and diagnostic needs of the company.

MHS is partnering with Desert Laboratories Inc in the United States to set up a factory to manufacture medical laboratory molecular tests for Covid-19, HIV, and tuberculosis, among others.

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Medical products

3 actions to capitalize on the dynamism of the medical products industry

This story originally appeared on Zacks

The COVID-19 pandemic, which has proven to be a biological crisis of an unprecedented nature, has changed the very nature and dynamics of the healthcare industry. Zacks’ medical products industry has also not been immune to the pandemic, and has been hit hard by widespread supply chain disruptions and postponement of elective proceedings. However, the medical products space has seen a substantial recovery, mainly due to the easing of previous restrictions and the acceleration of vaccinations. Apart from this, the slow resumption of elective procedures, the growing demand for in vitro diagnostics (IVD) and the growing reliance on artificial intelligence (AI) and robotics are expected to favor industry participants. in the coming days. Despite a pandemic-induced disruption triggered by the Delta variant, particularly during August and September, industry players have yet to show signs of slowing down. Industry participants love Abbott Laboratories ABT, Bio-Rad Laboratories, Inc. BIO and Hill Rom Holdings, Inc. HRC are likely to take advantage of the factors mentioned above.

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Medical products

Intensify actions to fight substandard and falsified medical products. Urgent appeal to “false breakers”

“Health is not a hoax – Fight the fakes” is the slogan for this year’s Fight the Fakes week. The aim is to highlight how substandard and falsified medicines pose serious risks to human health and have disastrous consequences for the well-being of communities and the socio-economic stability of each country. They deserve much more attention in international fora.

Fight the Fakes Alliance invites organizations and individuals around the world to become fake busters for this year’s Fight the Fakes week, December 6-12, and to help raise awareness of the dangers involved.

Sometimes substandard and falsified drugs can have tragic consequences. They are contributing to the development of the second global health emergency after COVID-19: antimicrobial resistance and drug-resistant infections. They create mistrust in drugs, health professionals and health systems and block the socio-economic development of a country. The problem is most acute in low- and middle-income countries, with estimates suggesting that up to 1 in 10 medical products are either substandard or falsified.

Since the start of the COVID-19 pandemic, diagnostic tests, personal protective equipment (PPE), potential therapies and vaccines have been found to be falsified across the world. The World Health Organization (WHO) has issued several medical product alerts related to COVID-19 vaccines and treatments over the past two years, while the Infectious Disease Data Observatory collects hundreds of reports from the field public on substandard and falsified COVID-19 medical products. and COVID-19 vaccines.

As the rollout of COVID-19 vaccination accelerates, criminals are capitalizing on shortages or barriers to access, but also waves of vaccine hesitation. It may also accelerate the spread of counterfeit products that are unrelated to COVID-19, proving a flourishing global business of substandard and falsified medical products, without regard for the health impacts.

About Fight the Fake Alliance

The Fight the Fakes Alliance (aka “Fight the Fakes”) is a non-profit, multi-party association that aims to raise awareness of the dangers of falsified and substandard medicines. He gives voice to those who have been personally affected and shares the stories of those working to end this threat to public health. He seeks to build a global movement of organizations and individuals who will shed light on the threat these so-called drugs pose to patient safety and health systems and to achieving universal health coverage. The diverse members of Fight the Fakes share the belief that coordination among all stakeholders working along the medical supply chain is essential if we are to tackle this threat to global health.




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Medical products

Medical Products Supply Chain Weekly Review – FDA Approves Pfizer and Moderna Booster for All Adults | Alston & Bird

Over the past week, the FDA cleared the Pfizer and Moderna booster injections for all adult age groups, while the CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended the Moderna vaccine booster. for all adults. Pfizer has submitted an Emergency Use Authorization (EUA) application for its oral treatment with COVID-19. President Biden signed the Infrastructure Investments and Jobs Act and the Executive Order for its implementation. The FDA has issued updated guidelines for manufacturers of SARS-CoV-2 tests. Please see details of these and other supply chain developments below:

  • On November 15, the President signed the Law on Investment in Infrastructure and Employment (IIJA) and a decree to facilitate its implementation. IIJA Amends Homeland Security Act 2002 to Allow Secretaries of Homeland Security, Health and Human Services (HHS) Departments, and Veterans to Transfer Personal Protective Equipment (PPE) and Equipment medically necessary for the national stock under a production contract during a public health emergency declared by the secretary of the HHS. In general, the Secretary of Homeland Security, at the request of the Secretary of HHS, is authorized to transfer to HHS, for reimbursement, excess PPE or medically necessary equipment possessed by the Department of Homeland Security (DHS). The DHS Secretary must determine whether the requested personal or medically necessary protective equipment is surplus equipment and certify that the transfer of such equipment will not have a negative impact on the health or safety of officers, employees or subordinates. treating DHS. The IIJA is also amending the Public Health Services Act to allow the Secretary of HHS, in coordination with the Secretary of DHS, to sell drugs, vaccines (and other biologicals), medical devices, or supplies. within the national stock to a federal agency, nonprofit, state, or local, tribal, or territorial entity. Products sold must be within one year of expiration or determined to be no longer needed in inventory due to advances in medical or technical capacity. The IIJA also includes a subtitle “Make PPE in America Act” which requires the development of a short-term (three-year) and long-term strategy for the national production of PPE. An Infrastructure Implementation Working Group has been established to oversee the implementation of the law. The working group will be co-chaired by Mitch Landrieu, White House Infrastructure Implementation Coordinator, and Brian Deese, Director of the National Economic Council.
  • On November 15, the FDA updated its policies regarding COVID-19 test review expectations and released several policies that provide guidance to manufacturers. The FDA’s goal is to ensure that the tests are reliable and accurate. The update included the following:
    • The FDA has re-issued the “Policy for Testing for Coronavirus-2019 Disease During Public Health Emergency (Revised),” which applies to tests that use diagnostic and serological methodology. Manufacturers can submit EUA requests for home and point-of-care testing, high-volume laboratory molecular diagnostic testing, high-volume laboratory and point-of-care antibody testing, and funded testing by the US government agency. All other types must use traditional pre-market channels.
    • The FDA has published the “Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing”. This EUA applies to certain SARS-CoV-2 serial use nasal swab tests, which are used in testing programs by schools, workplaces or community groups. Testing should be performed in a single CLIA certified laboratory.
    • The FDA reissued the EUA, “Laboratories that have developed a molecular test (LDT) for coronavirus disease 2019 (COVID-19)”. In its review of current policies and the changing needs of the pandemic, the agency is prioritizing serial use testing and has updated its conditions for authorizing molecular-based laboratory-developed tests. Additional tests may be permitted.
    • The FDA has issued guidance on its “Viral Transport Media Enforcement Policy During Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Due to the increase in serial testing, there is a need to increase the availability of transport media for clinical specimens. The FDA created this guide to support this effort and provide a standard for media manufacturers. The guide specifically provides criteria for commercial manufacturers on validation, agency notification and labeling expectations. Additional guidance and expectations are included for manufacturers of alternative media types and saline transport media.
  • On November 16, Pfizer announced the submission of an EUA application for its COVID-19 oral antiviral drug, Paxlovid (ritonavir). The medicine is intended for home use in high-risk patients to prevent hospitalization and death. According to an interim review from the Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial, a phase 2/3 study, Paxlovid demonstrated a relative risk reduction of 89% (risk reduction absolute 6.2%) of hospitalization and death in participants 18 years and older at high risk for disease progression. Recruitment for the trial was discontinued upon recommendation of the Data Oversight Committee based on interim analysis data. Trials for standard risk patients and post-exposure prophylaxis are still ongoing. On the same day, Pfizer agreed to license Paxlovid to the Medicines Patent Pool, a United Nations-backed entity, to provide access to the drug to low- and middle-income countries. On November 18, Pfizer announced an agreement with the US government to supply 10 million courses of Paxlovid, subject to regulatory clearance from the FDA.
  • On November 16, the Center for Devices and Radiological Health (CDRH) updated the Medical Device Development Tools program documents landing page. The program is voluntary and supports sponsors in the development and evaluation of their medical devices with the aim of facilitating the review of CDRH. The program’s tools are evaluated and approved by the FDA and must be capable of producing scientifically plausible results.
  • On November 17, the White House COVID-19 response team announced that the administration was planning to provide funding to increase vaccine production. The Department of Health and Human Services is in contact with manufacturing companies that can increase their vaccine production. The goal is to add at least one billion doses to the national supply through investments in infrastructure and training.
  • On November 19, the FDA cleared the Pfizer and Moderna vaccines for use as a booster dose in all age groups 18 years and older. The agency based its decision on data from ongoing clinical trials and real-time results from vaccine use. The authorizations relate to a booster dose at least six months after the end of the initial series. The CDC ACIP then met and unanimously recommended that the Moderna vaccine be allowed for people 18 years of age and older. The committee’s decision has been forwarded for approval to CDC director Dr. Walensky and the FDA.

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