Product: Drugs Recipient: Recipient Name Dr. Krishna Prasad Chigurupati Recipient Title Chairman and Managing Director Granules India Limited Survey No 160/A, 161/E, 162 and 174/A, Gagillapur […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 702106 Dear Sir/Madam: This letter concerns your […]

Product: Drugs Recipient: Recipient Name Kelly Chan TKTX Store 391 Sutter StreetSan Francisco, CA 94108United States [email protected] Issuing Office: Center for Drug Evaluation and Research (CDER) […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 697051 Dear Sir/Madam: This letter concerns your […]

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 698435 Dear Sir/Madam: This letter concerns your […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-44 Product: Drugs Recipient: Recipient Name Mr. Jason Archer Recipient Title General Manager Chem-Tech, Ltd. 1006 Business […]

[embedded content]   Any pet owner who has been told their animal has cancer knows the two emotions: anxiety for the beloved pet’s life, and hope […]

Image Español When you take prescription or over-the-counter medications, do you also take a vitamin, mineral, or other dietary supplement? Have you considered whether there is […]

In 2017, FDA’s Center for Drug Evaluation and Research (CDER) embarked on an initiative to modernize the New Drugs Regulatory Program.  For more information on this […]