Blog — Clinical Pathways

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PDUFA

FDA Issues Revised Draft Guidance on Formal Meetings Between FDA and Applicants of PDUFA Products

10/24/2023

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On September 21, 2023, the Food and Drug Administration (FDA) released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” to advise on formal meetings between the agency and sponsors or applicants involved in the development and review of investigational products. The new draft guidance replaces the previous version issued in December 2017.

Advancing Real-World Evidence (RWE) Program FAQ

08/08/2023

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The US Food and Drug Administration (FDA) recently updated their website to include a Frequently Asked Questions page for their Advancing Real-World Evidence (RWE) Program. The Advancing RWE Program was announced in October 2022 and is intended to support new labeling claims, a new indication for an approved drug, or to satisfy post approval requirements.

Updated CPGM for PAI - PDUFA VII Performance Goal

12/20/2022

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The U.S. Congress reauthorized the Prescription Drug User Fee Act (PDUFA VII) for fiscal years 2023-2027 on September 30, 2022. PDUFA began in 1992 and must be reauthorized every five years. Starting in 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) included the fifth reauthorization of PDUFA and the third reauthorization of the Medical Device User Fee Act (MDUFA), which began in 2002.

MDUFA V Proposed Recommendations for Reauthorization Ready for Public Meeting

03/29/2022

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The US Food and Drug Administration (FDA) published a press release confirming that the FDA and medical device industry stakeholders reached an agreement on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Amendments of 2023 (MDUFA V). The first authorized user fee for medical device occurred with the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Public Meeting with the FDA: PDUFA Reauthorization

08/24/2021

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The US Food and Drug Administration (FDA) is holding a public meeting to discuss recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA). Stakeholders are invited to discuss their opinions on recommended enhancements for the next reauthorization. PDUFA began in 1992 and must be reauthorized every five years.