Reference #: FEI 3006731547 Product: Drugs Recipient: Recipient Name Mr. Young-Gi Son Recipient Title President Natuzen Co., Ltd. 289 Namdongdong-RoNamdong-guIncheon21639South Korea Issuing Office: Center for Drug […]

Potential applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and ANDA preparation processes. For inquiries related […]

THIS THURSDAY: Register today for ourMarch 13 update on FDA’sefforts related to model master files (MMFs). Don’t miss Model Master Files:Advancing Modeling and Simulation in GenericDrug […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Joseph Young Recipient Title CEO Pico IV Inc. 1610 R St. Ste 300Sacramento, CA 95811United States [email protected] […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-49 Product: Drugs Recipient: Recipient Name Mr. V. Vishnu Murthy Raju Recipient Title Managing Director Shree Jaya Laboratories PVT. […]

Delivery Method: Via Email Reference #: 320-25-47 Product: Drugs Recipient: Recipient Name Changhui Qi Linghai ZhanWang Biotechnology Co., Ltd No. 7-2, Dalinghe Industrial ParkLinghai ShiJinzhou ShiLiaoning […]

FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling. Human prescription drug labeling: Contains a summary of […]

For Immediate Release: March 07, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Wednesday, […]

Docket Number: FDA-2019-D-1615 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of the Commissioner, Office of […]