Three stakeholders raise concerns with an FDA guidance on gastroparesis drug development.
FDA grants Garwood Medical a Breakthrough Device designation for its BioPrax device for eliminating biofilm infections on prosthetic knees.
FDA makes available a draft guidance entitled Drug Master Files.
Several lawmakers write FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recall of its hypoparathy...
Bayer submits a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg...
FDA clears a Canon Medical Systems 510(k) for its Advanced Intelligent Clear-IQ Engine (AiCE) for use on the Aquilion Precision CT Scanner.
FDA posts a Form-483 from a July inspection at Ram Pharmas Idaho Falls, ID outsourcing facility.