Last week, the FDA granted EUA for the Pfizer-BioNTech vaccine for children aged 5 to 11. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The administration organized 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 nonprofits launched the Bespoke Gene Therapy Consortium (BGTC) to optimize and streamline the gene therapy development process. In particular, the BGTC will streamline regulatory requirements and processes for FDA approval of gene therapies, including the development of standardized approaches for preclinical testing (eg, toxicology studies).
- On October 29, the FDA cleared the emergency use of the Pfizer-BioNTech vaccine for children aged 5 to 11. The authorization is for a two-dose regimen, and each dose is less than the prescribed dose for persons 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 vaccine for use in this population.
- On October 31, President Biden convened a summit with the European Union and 14 other countries to discuss transnational cooperation to strengthen supply chains. The conversation focused specifically on the diversification of the supply chain ecosystem, covering raw materials, manufacturing of intermediate and finished products, shipping, logistics, warehousing and distribution. President Biden also announced initiatives to address supply chain disruptions, including releasing stocks, funding technical assistance in Mexico and Central America, and a commitment to host future summits on the Supply Chain.
- On November 3, the administration announced it would release 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 ships at berth awaiting docking, import volume in port and retail stocks. The Administration’s goal is to use the data to help stakeholders assess the health of the supply chain and foster future collaborations.
- On November 4, the FDA released a draft guideline for industry, Content of Premarket Submissions for Device Software Functions. The guide aims to provide industry with the required information that should be included in a pre-market submission that will help the FDA assess the safety and effectiveness of software functions included in a medical device (SiMD), as well as software that functions as a medical device (SaMD). The guidelines will apply to all types of pre-market submissions, including PMA, 510 (k) and De Novo classification requests. Comments are due in 90 days.
- The Center for Devices and Radiological Health has released 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 released if resources require it. allow (B-List). The CDRH will also carry out a retrospective review of the guidance documents for the years 1982, 1992, 2002 and 2012.