In the past week, senior FDA officials revealed that the FDA is preparing for more inspections and exploring new inspection technologies. In addition, the Biden Administration announced a loan of AstraZeneca vaccines to Mexico and Canada. Please see details for these and other supply chain developments below:
- On March 16, the FDA issued a new supplemental template for COVID-19 test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing. The agency also issued a fact sheet that outlines considerations for selecting a test for use in a screening testing program.
- On March 17, the FDA announced that it had granted marketing authorization for the BioFire Respiratory Panel 2.1 (RP2.1), using the De Novo premarket review pathway. This is the first COVID-19 diagnostic test that has received marketing authorization through a traditional premarket review process. The test had been distributed under an EUA, which the FDA revoked when it granted the De Novo request.
- On March 18, in an FDA Voices article, Janet Woodcock, acting commissioner of the FDA, and Judy McMeekin, associate commissioner for regulatory affairs, discussed FDA inspections during the COVID-19 pandemic. In particular, they stated that:
- The FDA will continue to study “new technologies and tools for facility oversight, including the further use of remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences or screen sharing), and will work with industry to expand their use.”
- The agency is “pursuing agency-wide preparedness efforts for resuming a more normal state of operations, which will factor in how best to address inspectional activities that were paused due to the pandemic.”
This article is likely a response to the Government Accountability Office (GAO) testimony in the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies hearing “FDA’s Foreign Drug Inspections Program” held on March 9. We reported on the hearing in last week’s review.
- On March 19, the White House COVID-19 Response Team announced that the U.S. is lending around 4 million doses of its releasable AstraZeneca vaccines to Mexico and Canada, where the vaccine has already been approved.
- On March 22, AstraZeneca announced that the U.S. Phase III trial of its COVID-19 vaccine demonstrated statistically significant efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization. The company will prepare for the primary analysis to be submitted to the FDA for EUA in the coming weeks. On March 23, the National Institutes of Health (NIH) announced that the Data and Safety Monitoring Board (DSMB) had expressed concern that AstraZeneca may have included outdated information in the initial data of its COVID-19 vaccine clinical trial, which may have provided an incomplete view of the efficacy data.
Please do not hesitate to contact us if you have any questions about these developments.