Pfizer-supported research shows its investigational bivalent RSV prefusion F protein-based vaccine succeeded in preventing RSV-associated lower respir...
The International Council for Harmonization gives final approval to a guidance on assessing and controlling mutagenic impurities in drugs to limit can...
FDA asks for input on five questions that could be included in a revision of a medical device patient perspective guidance.
Federal Register notice: FDA extends the comment period for a draft guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Safety ...
CBER issues an untitled letter to Fidia Pharma USA after reviewing the companys Web sites and determining that its cell/tissue products require a BLA ...
Federal Register notice: FDA makes available a draft guidance on incorporating clinical outcome assessments into endpoints.
Federal Register notice: FDA makes available a draft guidance entitled Notification of a Permanent Discontinuance or Interruption in Manufacturing Und...
FDA commissioner Robert Califf and chief scientist Namandj Bumpus withdraw Covis Pharmas preterm birth drug Makena and its generics from the market ef...
