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August 10, 2022

Compounding Activities | COVID-19

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 […]
August 10, 2022

2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee)

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 […]
August 10, 2022

2019 Meeting Materials, Bone, Reproductive and Urologic Drugs Advisory Committee (formerly Advisory Committee for Reproductive Health Drugs (ACRHD))

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 […]
August 9, 2022

Public Webinar – Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments – Draft Guidance – 09/09/2022

On This Page Date: September 9, 2022 Time: 12:00 PM – 3:00 PM ET On September 9, 2022, the U.S. Food and Drug Administration (FDA) is […]
August 9, 2022

FDA works to avoid shortage of sitagliptin following detection of nitrosamine impurity

[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 […]
August 9, 2022

Ariella Naturals – 632509 – 08/04/2022

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 […]
August 9, 2022

JB Exchange Inc./Justified Laboratories – 631521 – 08/04/2022

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 […]
August 9, 2022

Amazon.com, Inc. – 629452 – 08/04/2022

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 […]
August 8, 2022

Rena’s Organic – 613036 – 02/11/2022

Delivery Method: Via Email Product: Dietary SupplementsDrugsFood & Beverages Recipient: Recipient Name Ms. Rena S. Greenberg Recipient Title Registered Agent Rena’s Organic 414 26th St WestBradenton, […]
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