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FDA in 2020: COVID Vaccine and OTC Ranitidine Drugs


Wednesday, December 23, 2020
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well.
Continued Progress on Non-COVID Priorities… 
Besides the obvious scientific, technical, and regulatory work that FDA and other stakeholders have been doing all year to mount a comprehensive response to the emergence of SARS-CoV-2 as a pandemic pathogen, the agency’s work on other high-priority human drug and biological product regulatory programs continued during 2020. FDA has demonstrated a fairly impressive ability to manage a huge number of competing priorities, even as certain areas like pre-approval inspections and re-inspections of facilities seeking removal from an import alert have suffered in the face of tra ....

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