An FDA advisory committee votes unanimously (22 to 0) to recommend the agency grant Moderna an emergency use authorization for its Covid-19 vaccine in...
FDA publishes a draft International Council for Harmonization guidance on quality risk management with no new regulatory expectations.
Federal Register notice: FDA corrects a 5/24 notice on a draft guidance being made available entitled "Blood Pressure and Pulse Donor Eligibility Requ...
As FDA prepares for a 6/14-15 advisory committee meeting on pediatric Covid-19 vaccines, agency briefing documents find the Pfizer-BioNTech and Modern...
Federal Register notice: FDA extends the comment period for a 2/16 notice that requested comments on antimicrobial drug use practices in companion ani...
A new JAMA online study finds that FDA reviews and approves new oncology therapies much faster and sooner than the EMA.
Federal Register notice: FDA renews its Science Advisory Board to the National Center for Toxicological Research for an additional two years.
A February inspection at Rentschler Biopharmas German drug substance manufacturing plant results in a nine-item FDA-483 that cites significant GMP vio...