On June 27, 2022, the FDA announced the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed […]

FDA and state pharmaceutical regulators meet regularly to advance their collective efforts to improve the quality of compounded drugs and protect consumers from unsafe compounded drugs. […]

Docket Number: FDA-2023-D-0093 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: FEI 3010165392 Product: Drugs Recipient: Recipient Name Mr. Alok K. Garg Recipient Title […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Alok K. Garg Recipient Title Managing Director Medgel Private Limited Plot No.: 19-20, Special Economic Zone, Phase-II, […]

Docket Number: FDA-2025-D-0507 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

On This Page Date: May 29, 2025 Time: 12:00 p.m. – 1:00 p.m. ET Speaker  Jayaleka J. Amarasinghe, Ph.D. Microbiologist Winchester Engineering and Analytical Center (WEAC)Office of Specialty […]

1 Columbia University Medical Center New York, New York 2 Brigham and Women’s Hospital Boston, Massachusetts 8 University of Kansas Medical Center Kansas City, Kansas 10 […]

On This Page Date: July 11, 2025 Time: 9:00 a.m. – 2:00 p.m. ET The Food and Drug Administration (FDA or Agency) is announcing a public […]