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.
FDA grants Dascena a breakthrough device designation for its GI Bleed Risk Alert System, a cloud-based software application that uses a machine learni...
Federal Register notice: FDA seeks comments on an information collection entitled Prominent and Conspicuous Mark of Manufacturers on Single-Use Device...