Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Mr. Bradley M. Rayner Recipient Title President Legacy Pharmaceutical Packaging LLC 13333 Lakefront DriveEarth City, MO […]
Mission The mission of the Controlled Substance Staff (CSS) is to promote the public health through the medical science-based assessment and management of drug abuse risks. […]
Subscribe for Updates FDA established the Compounding Quality Center of Excellence to support outsourcing facilities and related stakeholders in their efforts to provide high quality drugs for patients […]
GDUFA Guidance for Industry To view all GDUFA guidances, go to the Guidances for Drugs page, enter “GDUFA” in the search box, and under “Filter by,” […]
Image By: Hilary Marston, M.D., M.P.H., Chief Medical Officer and Ann Meeker-O’Connell, M.S., Director, Office of Clinical Policy Hilary Marston, M.D., M.PH. Clinical trials play a […]
FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are pleased to announce their partnership with the Critical Path […]
Docket Number: FDA-2022-D-2061 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for holders of Type II active pharmaceutical ingredient […]
Docket Number: FDA-2022-D-1981 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides information to applicants on how FDA intends to assign […]
Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
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