Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-02 Product: Drugs Recipient: Recipient Name Ralph A. DeFronzo, M.D. Recipient Title Department of Medicine, […]

Product: Drugs Recipient: motionpharmacy.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: […]

Product: Drugs Recipient: cheaptrustedpharmacy.com Turks & Caicos Islands Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. John Yi Recipient Title General Manager Janssen Vaccines Corp., A Johnson & Johnson […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Gennady Sirota Recipient Title President Stellalife, Inc. P.O. Box 1204Northbrook, IL 60065United States [email protected] Issuing Office: Center […]

CLOZARIL (clozapine)    NDA 019758 Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA) Veterans Health Administration (VHA) medical and pharmacy records  Descriptive study In […]

For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) […]

Docket Number: FDA-2025-D-0918 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

The Office of Biostatistics (OB) conducts independent research on statistical methodologies relevant to CDER’s scientific mission and regulatory review process for publication. OB research spans such […]