October 11, 2022

Legacy Pharmaceutical Packaging LLC – 633735 – 10/03/2022

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 […]
October 11, 2022

Controlled Substance Staff

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. […]
October 7, 2022

Compounding Quality Center of Excellence

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 […]
October 6, 2022

GDUFA Guidances and MAPPs

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,” […]
October 6, 2022

FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule

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 […]
October 6, 2022

FDA Launches AATD Pre-Consortium Partnership with the Critical Path Institute

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 […]
October 6, 2022

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

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 […]
October 6, 2022

Facility Readiness: Goal Date Decisions Under GDUFA

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 […]
October 5, 2022

Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) Roster

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 […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0