Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This was a big news week for FDA watchers – we saw the release of the Biden administration’s FY 2024 budget request and FDA’s roadmap for how it will handle dozens of COVID-19 pandemic era guidances now that the COVID-19 public health emergency (PHE) is winding down.
In a Federal Register notice on Friday, FDA laid out its plans to sunset, phase out, or transition the 72 guidances it issued under the PHE declaration, which is set to expire on 11 May 2023. The guidances span all of FDA’s product centers, except for the Center for Tobacco Products, and cover topics including the agency’s watershed guidances on the development and licensure of COVID-19 vaccines, its expectations for emergency use authorization (EUA) submissions for said vaccines and guidance on remote interactive evaluations during the PHE.
The dozens of guidances also applied to various minutiae under FDA’s remit that were hit by pandemic-related disruptions, including enforcement policies for more than a dozen medical devices, tests and digital health products; temporary flexibilities for food and nutritional labeling; exceptions to risk evaluation and mitigation strategy (REMS) and Drug Supply Chain Security Act requirements; and recommendations on reporting changes to glass vials and stoppers due to shortages…
