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Federal Register notice: FDA extends the comment period for a draft guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Safety ...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Federal Register notice: FDA makes available a draft guidance on incorporating clinical outcome assessments into endpoints.
Federal Register notice: FDA makes available a draft guidance entitled Notification of a Permanent Discontinuance or Interruption in Manufacturing Und...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...
FDA clears a restor3d 510(k) for the Axiom PSR System for use with the companys Kinos Axiom Total Ankle System.
