12/20/2022
Photo by Myriam Zilles on Unsplash
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. PDUFA provides funding to the FDA for faster regulatory review of new drugs or biologics and MDUFA does the same for new devices. Although the fees appear to be large, a delay in review can cost the sponsor company even more in lost revenue. Reauthorization is required for the FDA to continue to collect user fees to fund their review.
One of the performance goals in the PDUFA VII commitment letter is for the US Food and Drug Administration (FDA) to notify the drug manufacturer a minimum of 60 days prior to a Pre-Approval Inspection (PAI). PAIs are conducted by the FDA to evaluate a drug manufacturer that is listed in the Chemistry, Manufacturing, and Controls (CMC) section of a New Drug Application (NDA). See our blog “When Does the FDA Perform PAIs?” for more information. Another related CPGM for Drug Quality Assurance was also updated. The updated CPGMs includes elements from:
ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality System
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Are you inspection ready? Clinical Pathways can help! Contact us at info@clinicalpathwaysresearch.com for more information.
- The Clinical Pathways Team
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