FDA releases six final and one draft guidance to further gene therapy product development.
FDA releases the FDA-483 with four observations from an inspection at the Athenex Pharma Solutions outsourcing facility.
FDA says Medline Industries ethylene oxide medical device sterilization facility in Waukegan, IL, has been voluntarily closed since 12/13/19 to finish...
FDA requires a new warning and updates on clozapine products and related constipation risks, which can progress to serious bowel complications.
Federal Register notice: FDA sends to OMB a proposed Study of Oncology Indications in Direct-to-Consumer Television Advertising.
FDA warns Chinas Sunstar Guangzhou about CGMP violations in its production of finished drugs.
Discussions from a joint FDA-MHRA workshop on good clinical practice are published by the American Society for Clinical Pharmacology and Therapeutics.
FDA warns Draegar Medical about manufacturing medical devices without an approved PMA or IDE and with Quality System violations.