Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Humanitarian Use Devices (HUD) 21 CFR Part 81...
The FDA Office of Clinical Pharmacology 2020 annual report says it met or exceeded all of its goals for 2020 despite also being very involved in the a...
FDA releases summaries from two meetings of the FDA/industry premarket subgroup involved in PDUFA 7 reauthorization discussions.
Two Certara consultants describe ways drug developers can help FDA speed the NDA and BLA approval process.
FDA reviewers support an emergency use authorization for Janssen Biotechs single intramuscular Covid-19 vaccine injection.
FDA extends to 3/31 the timeframe for API and finished drug manufacturers to complete nitrosamine risk assessments.
CDER publishes a revised Medical Policy Council MAPP.
Sedgwick Brand Protection says medical device manufacturers should be preparing for the likely revocation of emergency use authorizations in 2021.