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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.

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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

Rare Pediatric Disease Priority Review Voucher Program Expiration Threat: The FDA’s popular voucher program for rare pediatric diseases is currently scheduled to expire as of September 30, 2024 unless it is renewed by Congress.

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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

The following PDUFA dates were obtained from publicly available sources.

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