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 […]

For Immediate Release: September 19, 2025 Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth […]

FDA researchers are investigating the utility of pharmacodynamic, or PD, biomarkers to demonstrate biosimilarity. This research can potentially help developers demonstrate that their proposed product is […]

Product: Animal & VeterinaryDrugs Recipient: Recipient Name Michael Strobel Recipient Title CEO Aurora Pharmaceutical 1196 Highway 3 SouthNorthfield, MN 55057United States Issuing Office: Center for Veterinary […]