[ Price : $8.95]
The FDA Office of Clinical Pharmacology 2020 annual report says it met or exceeded all of its goals for 2020 despite also being ve...[ Price : $8.95]
FDA releases summaries from two meetings of the FDA/industry premarket subgroup involved in PDUFA 7 reauthorization discussions.[ Price : $8.95]
Two Certara consultants describe ways drug developers can help FDA speed the NDA and BLA approval process.[ Price : $8.95]
FDA reviewers support an emergency use authorization for Janssen Biotechs single intramuscular Covid-19 vaccine injection.[ Price : $8.95]
FDA extends to 3/31 the timeframe for API and finished drug manufacturers to complete nitrosamine risk assessments.[ Price : $8.95]
CDER publishes a revised Medical Policy Council MAPP.[ Price : $8.95]
Sedgwick Brand Protection says medical device manufacturers should be preparing for the likely revocation of emergency use authori...[ Price : $8.95]
FDA grants Dascena a breakthrough device designation for its GI Bleed Risk Alert System, a cloud-based software application that u...