[3/11/2025] FDA is alerting the public and industry to the results of new agency testing of 95 acne products containing benzoyl peroxide for possible benzene contamination. […]

For Immediate Release: March 11, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]

Reference #: FEI 3010972581 Product: Drugs Recipient: Recipient Name Mr. Tu Yongjun Recipient Title President and Founder Zhejiang Tianyu Pharmaceutical Co Ltd Jiangkou Development ZoneHuangyan QuTaizhou […]

Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Yongjun Tu Recipient Title Chief Executive Officer and Chairman of the Board Zhejiang Tianyu Pharmaceutical […]

Downloadable Data Files for the Orange Book The compressed (.ZIP) data file unzips into three files, whose field descriptions appear below. All three files are in ASCII […]

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 […]