HHS and the Justice Department issue a report on the FY 2017 healthcare fraud and abuse control program.
FDA approves a Novartis NDA for Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients...
Collegium Pharmaceutical asks FDA to reject NDAs for extended-release oxycodone products that dont meet requirements the company wants to have specifi...
Federal Register notice: FDA seeks the participation of consumer organizations in the selection of voting and nonvoting consumer representatives to se...
FDA issues an FDA-483 with 13 observations from an inspection at Indias Alkem Laboratories.
FDA publishes an overview guidance on using performance criteria under the expanded abbreviated 510(k) program.
FDA extends by three months its review of an AbbVie NDA for elagolix in endometriosis-associated pain to review additional information related to the ...
Innovative Health Solutions asks FDA to require pre-clinical and clinical trials for any proposed devices demonstrating substantial equivalence to its...