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August 30, 2022

First Strike Pet Products – 639799 – 08/15/2022

Delivery Method: Via Email Product: Animal & VeterinaryDrugs Issuing Office: Center for Veterinary Medicine United States WARNING LETTER August 15, 2022 RE: 639799 Dear (b)(6): This […]
August 29, 2022

FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth […]
August 26, 2022

FDA’s Sentinel Initiative

 Sign up for E-mail Updates Transforming how we monitor the safety of FDA-regulated products Monitoring the safety of its regulated products is a major part of the […]
August 26, 2022

Anesthetic and Analgesic Drug Products Advisory Committee Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
August 26, 2022

Nonprescription Drugs Advisory Committee Roster

As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on […]
August 26, 2022

FDA/PHUSE Computational Science Symposium – 09/19/2022

On This Page Date: September 19 – 21, 2022 Day1: Mon, Sep 19 3:00 PM – 7:00 PM ET Day2: Tue, Sep 20 9:00 AM – […]
August 26, 2022

Q2(R2) Validation of Analytical Procedures

Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline presents a discussion of elements for […]
August 26, 2022

Q14 Analytical Procedure Development

Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline describes science and risk-based approaches for […]
August 26, 2022

M12 Drug Interaction Studies

Docket Number: FDA-2022-D-1527 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline provides recommendation to promote a consistent […]
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