CDRH director Jeffrey Shuren says customers should follow a Cardinal Health recommendation not to use lots of Level 3 surgical gowns and PreSource pro...
FDA posts information about the 2018 Right to Try law and how certain patients may be able to access unapproved drugs and biologics under it.
FDA approves an ANI Pharmaceuticals ANDA for potassium citrate extended-release tablets USP, 10 mEq and 15 mEq.
FDA clears a Cleveland Clinic 510(k) for patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea.
Federal Register notice: FDA makes available a draft guidance entitled Pediatric Study Plans for Oncology Drugs: Questions and Answers.
Attorneys Jeffrey Gibbs and McKenzie Cato say that FDA advisory committee meetings to review product applications may become a thing of the past.
FDA accepts for priority review a Clovis Oncology supplemental NDA for Rubraca (rucaparib) and its use as monotherapy treatment in certain dult patien...
FDA accepts for review a Neovasc PMA for its Neovasc Reducer for treating refractory angina.