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Reemergence of Brucella abortus, Israel, 2021

by | Mar 11, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: National Brucella Reference Laboratory, Kimron Veterinary Institute,...

Pico IV Inc. – 700591

by | Mar 11, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Joseph Young Pico IV Inc. 1610 R St. Ste 300Sacramento, CA 95811United States Support@picoiv.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERMarch 6,...

Shree Jaya Laboratories PVT. LTD. – 698690

by | Mar 11, 2025 | News

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. LTD. Plot No. 11, Road No. 3, ALEAP Industrial EstateNear Pragathi Nagar,...

ANDA Forms and Submission Requirements

by | Mar 11, 2025 | News

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 to ANDAs pending filing review and the status of pending suitability petitions, please...