In the past week, the FDA granted an EUA for the Pfizer-BioNTech vaccine for use in children 5–11 years of age. The agency also participated in the launch of the Bespoke Gene Therapy Consortium. The Administration held a global supply chain summit to strengthen cooperation and advocate for diversification of supply chains. Please see details for these and other supply chain developments below:
- On October 27, the FDA, the National Institutes of Health, 10 pharmaceutical companies, and five nonprofit organizations 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 the FDA approval of gene therapies, including developing standardized approaches to preclinical testing (e.g., toxicology studies).
- On October 29, the FDA authorized the emergency use of the Pfizer-BioNTech vaccine for children 5 through 11 years of age. The authorization is for a two-dose regimen, and each dose is lower than the dose prescribed for individuals 12 years of age and older. The vaccine demonstrated 90.7% effectiveness in preventing COVID-19 in children 5–11 years of age. Following the decision, the CDC endorsed the vaccine’s use in this population.
- On October 31, President Biden held a summit with the European Union and 14 additional countries to discuss cross-country cooperation to strengthen the supply chains. The conversation focused specifically on diversification of the supply chain ecosystem, covering raw materials, intermediate and finished goods manufacturing, shipping, logistics, warehousing, and distribution. President Biden also announced initiatives to combat supply chain disruptions, including stockpile releases, funding for technical assistance to Mexico and Central America, and a commitment to host future supply chain summits.
- On November 3, the Administration announced that it will be publishing a dashboard to show metrics that track progress and activities at the ports of Los Angeles and Long Beach. The dashboard will provide data on ships at bay waiting to dock, the import volume in port, and retail inventories. The Administration’s goal is to use the data to help stakeholders assess the health of the supply chain and foster collaborations in the future.
- On November 4, the FDA released draft guidance for industry, Content of Premarket Submissions for Device Software Functions. The guidance is intended to provide industry with the required information that should be included with a premarket submission that will help the FDA evaluate the safety and effectiveness of the software functions included in a medical device (SiMD), as well as software that functions as a medical device (SaMD). The guidance will apply to all premarket submission types, including PMAs, 510(k)s, and De Novo classification requests. Comments are due in 90 days.
- The Center for Devices and Radiological Health published its proposed list of guidance documents to be published in FY2022. The listing includes its priorities (A-List) and those guidance documents to be released if resources permit (B-List). The CDRH will also conduct a retrospective review of guidance documents for the years 1982, 1992, 2002, and 2012.