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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices
procedural goals under PDUFA II.
However, concerns grew that overworked review teams often had to return applications as approvable because they did not have the resources and sufficient staff time to work with the sponsors to resolve issues so that applications could be approved in the first review cycle.
A sound financial footing and support for limited postmarket risk management were key themes of PDUFA III. Base user fee resources were significantly increased and a mechanism to account for changes in human drug review workload was adopted. PDUFA III also expanded the scope of user fee activities to include postmarket surveillance of new therapies for up to 3 years after marketing approval. FDA committed to the development of guidance for industry on risk assessment, risk management, and pharmacovigilance, as well as guidance to review staff and industry on review management principles. The draft guidance for industry entitled Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications GRMPs was originally published in April 2005 and was subsequently revised and republished in September 2018 available at https www.fda.gov/
media/72259/download 83 FR 48435, September 25, 2018.1 Initiatives to improve application submission and Agency-sponsor interactions during the drug development and application review processes were also adopted.
With PDUFAs reauthorization under FDAAA Title I PDUFA IV, FDA
obtained a significant increase in base fee funding and committed to full implementation of GRMPs, which included providing a planned review timeline for premarket review, development of new guidance for industry on innovative clinical trials, modernization of postmarket safety, and elimination of the 3-year limitation on fee support for postmarket surveillance.
Additional provisions in FDAAA Titles IV, V, and IX gave FDA additional statutory authority that increased the preand postmarket review process requirements, added new deadlines, and effectively increased review workload.
Specifically, the new provisions expanded FDAs drug safety authorities, such as the authority to require risk evaluation mitigation strategies REMS, 1 When final, this guidance will represent the FDAs current thinking on this topic. For the most recent version of a guidance, check the FDA
guidance web page at https www.fda.gov/
regulatory-information/search-fda-guidancedocuments.

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order safety labeling changes, and require postmarket studies.
Under Title I of FDASIA, the fourth renewal of PDUFA, FDA implemented a new review program the Program to promote greater transparency and increase communication between FDAs review team and the applicant on the most innovative products reviewed by the Agency. The Program applied to all new molecular entity NME NDAs and original BLAs received by the Agency from October 1, 2012, through September 30, 2017. The Program added new opportunities for communication between the FDA review team and the applicant during review of a marketing application, including mid-cycle communications and late-cycle meetings, while adding 60 days to the review clock to provide for this increased interaction and to address review issues for these complex applications. PDUFA V also required an assessment of the impact of the Program. The independent assessment of the Program entitled Assessment of the Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs in PDUFA V, is available at https
www.fda.gov/media/101907/download.
In August 2017, FDARA was enacted, which renewed the prescription drug user fee program for a fifth time. This iteration of the program continued and built upon the successes of PDUFA V.
In PDUFA VI, FDA and industry members agreed to continue the Program model developed in PDUFA V
to continue to promote the efficiency and effectiveness of the first cycle review process. PDUFA VI includes commitments to enhance regulatory science and expedite drug development by focusing on enhancing communication between FDA and sponsors during drug development, early consultation on the use of new surrogate endpoints, and exploring the use of real-world evidence for use in regulatory decision making, among other enhancements. This reauthorization also included commitments to enhance the use of regulatory tools to support drug development and review through incorporation of the patients voice in drug development, expanded use of a benefit-risk framework in drug reviews, and advancing the use of complex innovative trial designs and model informed drug development. More information on these commitments can be found in the PDUFA VI commitment letter at https www.fda.gov/media/
99140/download.
As part of the current authorization, FDA also modernized the user fee
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structure to improve program funding predictability, stability, and administrative efficiency. The new structure eliminated the supplement fees, replaced the establishment and product fees with a program fee, and shifted a greater proportion of the target revenue to the new more predictable and stable annual program fee. The agreement also included commitments to enhance management of user fee resources through the development of a resource capacity planning capability and third-party evaluation of program resource management, along with the publication and annual update of a 5-year financial plan.
Recognizing the challenges with hiring in PDUFA V, the current authorization also includes several commitments to improve the hiring and retention of critical review staff through modernization of FDAs hiring system, augmentation of hiring staff capacity and capabilities, creation of a dedicated function focused on staffing the program, reporting on hiring metrics, and a comprehensive and continuous assessment of hiring and retention.
Annual performance reports for the PDUFA program can be found through FDAs web page PDUFA Performance Reports, available at https
www.fda.gov/about-fda/user-feeperformance-reports/pdufaperformance-reports. Additionally, a list of some public-facing deliverables developed to meet PDUFA VI
commitments is available on FDAs web page Completed PDUFA VI
Deliverables, available at https
www.fda.gov/industry/prescriptiondrug-user-fee-amendments/completedpdufa-vi-deliverables.
III. Proposed PDUFA VII
Recommendations In preparing the proposed recommendations to Congress for PDUFA reauthorization, FDA conducted discussions with the regulated industry and consulted with stakeholders, as required by the law. We began the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input on the reauthorization and announcing a public meeting that was held on July 23, 2020.2 The meeting included presentations by FDA and a series of panels with representatives of different stakeholder groups, including patient advocates, consumer groups, regulated industry, health professionals, and academic researchers. The materials 2 See Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments, 85 FR 35096, June 8, 2020.

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