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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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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