FDA clears a Synedgen 510(k) for its Catasyn Advanced Technology Wound Hydrogel for use under the direction of a health care professional and over-the...
Federal Register notice: FDA announces a 6/26 joint advisory committee meeting to review a Pain Therapeutics NDA for a proposed abuse-deterrent oxycod...
FDA warns Chinas Nox Bellow Cosmetics about CGMP violations in its production of finished pharmaceuticals.
FDA warns Cerno Pharmaceuticals about CGMP and misbranding violations in its production of finished drugs.
FDA posts a seven-item Form 483 following a 5/1 inspection of Biocons Bangalore, India drug substance and drug product manufacturing facility.
FDA posts a guidance on Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry: Controlled Correspondence Related to...
Federal Register notice: FDA establishes a public docket to assist with developing a policy or guidance document on assessing pH-dependent drug-drug i...