Amryt seeks FDA formal dispute resolution over a complete response letter it received in February for its NDA for Filsuvez (oleogel-S10), indicated fo...
Former Pharmatech CEO Raidel Figueroa pleads guilty to conspiring to defraud FDA, among other charges, in a case involving contaminated drug products.
FDA makes available a guidance entitled Providing Regulatory Submissions in Alternate Electronic Format.
FDA grants Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasound to temporarily di...
Federal Register notice: FDA seeks comments on an information collection extension entitled Protection of Human Subjects; Informed Consent; and Instit...
Federal Register notice: FDA makes available a draft guidance entitled Considerations for Rescinding Breakthrough Therapy Designation.
Federal Register notice: FDA makes available a draft guidance entitled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contami...
Federal Register notice: FDA makes available a final guidance entitled Assessing the Effects of Food on Drugs in INDs and NDAs Clinical Pharmacology ...