FDA is working to provide guidance to states and compounders on issues associated with compounding drugs during the COVID-19 pandemic. The agency’s guidance aims to protect […]
2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee) | FDA In this section: Obstetrics, Reproductive and […]
2019 Meeting Materials, Bone, Reproductive and Urologic Drugs Advisory Committee (formerly Advisory Committee for Reproductive Health Drugs (ACRHD)) | FDA In this section: Obstetrics, Reproductive and […]
[8/9/2022] FDA recently became aware of a nitrosamine impurity, Nitroso-STG-19 (known as NTTP), in certain samples of sitagliptin, a medicine used to treat type 2 diabetes […]
Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER August 4, 2022 RE: 632509 To […]
Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER August 4, 2022 RE: 631521 Dear […]
Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER August 4, 2022 RE: 629452 Dear […]
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