The World Health Organization releases for comment a draft guideline on a risk-based approach to data integrity.
FDA issues a draft guidance with recommendations for applicants and manufacturers of transdermal and topical delivery systems on information to includ...
Federal Register notice: FDA establishes a public docket for interested parties to nominate bulk drug substances or re-nominate bulk drug substances t...
Federal Register notice: FDA makes available a draft guidance for Industry #256 entitled Compounding Animal Drugs from Bulk Drug Substances.
CDRHer Joshua Chetta outlines provisions in a draft guidance proposing the new Safer Technology Program for Medical Devices.
FDA commissioner nominee Stephen Hahn sails through his Senate confirmation hearing 11/20 with praise and some resistance from lawmakers.
Federal Register notice: FDA announces a 12/13 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Horizon Pharma Ireland BLA f...
Federal Register notice: FDA announces a 1/16 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a Durect NDA for bupivacain...