FDA names Kaveeta Visisht to be associate commissioner for womens health.
FDA announces its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single-use medical devices...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug developers.
Federal Register notice: FDA seeks comments on a proposed information collection for Collection of Information for Participation in FDA Non-Employee F...
FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.
FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and treating stress urinary...
FDA issues Adamis Pharmaceuticals a complete response letter on its NDA for Adamis ZimHi (naloxone) high-dose injection for treating opioid overdose.
CDER Office of Prescription Drug Promotion sends Rockwell Medical an untitled letter after reviewing the companys Triferic Web page and finding false ...