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Medical Product Supply Chain Week in Review – November 4, 2021 – Food, Drugs, Healthcare, Life Sciences

United States: Medical Product Supply Chain Week in Review – November 4, 2021

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Last week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children ages 5 to 11. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration hosted a global supply chain summit to strengthen cooperation and advocate for the diversification of supply chains. Please see details of these and other supply chain developments below:

  • On October 27, the FDA, the National Institutes of Health, 10 pharmaceutical companies and five nonprofit organizations spear the Bespoke Gene Therapy Consortium (BGTC) to optimize and streamline the gene therapy development process. In particular, the BGTC will streamline regulatory requirements and FDA approval processes for gene therapies, including the development of standardized approaches for preclinical testing (eg, toxicology studies).
  • On October 29, the FDA authorized emergency use of the Pfizer-BioNTech vaccine for children 5-11 years old. The clearance is for a two-dose regimen, and each dose is lower than the dose prescribed for people 12 years of age and older. The vaccine has been shown to be 90.7% effective in preventing COVID-19 in children 5 to 11 years old. Following the decision, the CDC approved the use of the vaccine in this population.
  • On October 31, President Biden tenuous a summit with the European Union and 14 additional countries to discuss transnational cooperation to strengthen supply chains. The conversation focused specifically on diversifying the supply chain ecosystem, covering raw materials, manufacturing of intermediate and finished goods, shipping, logistics, warehousing and distribution. President Biden also announced initiatives to address supply chain disruptions, including the release of inventory, funding for technical assistance to Mexico and Central America, and a commitment to host future summits. of the supply chain.
  • On November 3, the administration announcement that it will publish a dashboard to show metrics that track progress and activity at the Ports of Los Angeles and Long Beach. The dashboard will provide data on vessels in berth waiting to berth, import volume in port and retail stocks. The administration’s goal is to use the data to help stakeholders gauge the health of the supply chain and foster collaborations going forward.
  • On November 4, the FDA published Draft Industry Guidelines, Content of Pre-Release Submissions for Device Software Features. The guidelines are intended to provide industry with the required information that must be included in a premarket submission that will help the FDA evaluate the safety and effectiveness of software functions included in a medical device (SiMD), as well as software that operate as a medical device (SaMD). The guidelines will apply to all types of premarket submissions, including PMAs, 510(k), and De Novo filings. Feedback is due in 90 days.
  • Center for Devices and Radiation Health Center for Devices and Radiation Health published its proposed list of guidance documents to be released in fiscal year 2022. The list includes its priorities (A list) and guidance documents to be published as resources permit (List B). The CDRH will also conduct a retrospective review of policy documents for the years 1982, 1992, 2002 and 2012.

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Joan J. Dean

The author Joan J. Dean