Federal Register notice: FDA submits to OMB for approval an information collection extension for Export of Food and Drug Administration-Regulated Prod...
FDA updates standards for acceptance of data from medical device clinical investigations held outside the U.S. to help ensure data quality and integri...
The DC federal court rejects a Ferring request that it enforce summary judgment against FDA in a case involving new molecular entity exclusivity for t...
FDA approves an Osmotica Pharmaceutical NDA for Osmolex ER (amantadine extended release tablets) for treating Parkinsons disease and drug-induced extr...
Office of Generic Drugs director Kathleen Uhl says the Offices regulatory science research program has made significant advances in five years on ques...
AllTrials.net says it will track and inform FDA of companies that have breached their FDAAA requirement to publish clinical trial results within 13 mo...
FDA releases its latest batch of Warning Letters that includes Casmara Cosmetics and Pacific Hospital Supply Co.
CDER issues a MAPP on procedures for issuing and overseeing clinical holds for INDs.