The Federal Trade Commission implements electronic filing to replace hard-copy submissions involving brand name and generic drug company agreements fo...
FDA approves a PTC Therapeutics supplemental NDA for Emflaza (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy...
FDA clears an Innovative Health Solutions de novo marketing request for the IB-Stim, the first medical device to aid in reducing functional abdominal ...
Insys Therapeutics agrees to pay $225 million and participate in an enhanced corporate integrity program to resolve civil and criminal charges involvi...
FDA announces that later this month generic drug applicants will be able to submit pre-assigned ANDA number requests through CDERs NextGen Portal.
FDA clears an Akonni Biosystems 510(k) for its TruDiagnosis System, a compact point-of-service molecular diagnostic device which includes the TruDx 20...
FDA issues a draft guidance to help sponsors develop drugs to treat nonalcoholic steatohepatitis with compensated cirrhosis.
FDA issues a draft guidance to help clinical trial sponsors enhance the diversity of trial participants.