Centers for Medicare & Medicaid Services (CMS) issues a proposed procedural notice outlining a new Medicare coverage pathway for breakthrough medical ...
FDA publishes a draft guidance on the formal dispute resolution and administrative hearing process for over-the-counter monograph drugs.
Federal Register notice: FDA announces the renewal of the Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expi...
Arrow International recalls its Arrow Endurance Extended Dwell Peripheral Catheter System due to the potential for catheter separation or leakage.
A Bloomberg newsletter covering India reports that Indian drug firms are sharing FDA inspection reports and their responses in an effort to improve in...
FDA grants Sarepta Therapeutics an accelerated approval for its BLA for Elevidys, the first gene therapy for treating pediatric patients aged four thr...
A 10/2022 inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL leads to a just-posted seven-item Form FDA-483 that cites significant...
FDA clears an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies.
