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FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.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 ...
Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applications and recordkeepin...