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...
Federal Register notice: FDA sends to OMB an information collection extension entitled Use of Public Human Genetic Variant Databases To Support Clinic...