Reports and Plans Mandated by FDARA
On August 18, 2017, the FDA Reauthorization Act (FDARA) (Public Law 115-52) was signed into law. FDARA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to revise and extend the user fee programs for human drugs, biologics, generic drugs, medical devices, and biosimilar biological products.
FDARA requires FDA to develop several different kinds of informational documents, including public reports, reports to Congress, communications plans, and others. FDA will post these items here as they become available.
FDARA Section 610 convene a Public Meeting
Section 610 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017 required FDA to convene a public meeting to discuss clinical trial eligibility criteria to inform a guidance on this subject. Pursuant to that mandate, and under a cooperative agreement with the Duke-Robert J. Margolis, MD, Center for Health Policy, FDA held a public workshop on April 16, 2018, entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.
- Evaluation Inclusion and Exclusion Criteria in Clinical Trials
Section 610 of FDARA also required that FDA publish a report within 90 days of the workshop summarizing the topics discussed. This report summarizes the major points explored with stakeholders during the workshop.
FDARA Section 710 Report on Servicing of Devices
FDARA Section 710 requires the FDA to post a report on the continued quality, safety, and effectiveness of devices with respect to servicing.
- FDARA Section 710 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices
Report containing information on the critical step of medical device servicing. It was informed by feedback from all stakeholder groups, among other information. The report also includes several actions that FDA intends on pursuing. (FDARA Section 710)
FDARA Section 902 Annual Report on Inspections
FDARA Section 902 required FDA to post calendar year information related to inspections of facilities necessary for the approval of specified human drugs and medical devices. On December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (FDORA) (Public Law 117-328) was signed into law. FDORA amended the reporting requirements of FDARA Section 902 and modified the reporting period from calendar year to fiscal year starting in 2023.
- FY 2023 FDARA Section 902 Annual Report on Inspections: Facility Inspections Necessary to the Approval of Specified Human Drugs and Medical Devices
Report containing data on actions taken during FY 2023 related to inspections that were necessary for the approval of specified human drugs and medical devices - CY 2022 FDARA Section 902 Annual Report on Inspections: Facility Inspections Necessary to the Approval of Specified Human Drugs and Medical Devices
Report containing data on actions taken during CY 2022 related to inspections that were necessary for the approval of specified human drugs and medical devices - CY 2021 FDARA Section 902 Annual Report on Inspections: Facility Inspections Necessary to the Approval of Specified Human Drugs and Medical Devices
Report containing data on actions taken during CY 2021 related to inspections that were necessary for the approval of specified human drugs and medical devices - CY 2020 FDARA Section 902 Annual Report on Inspections: Facility Inspections Necessary to the Approval of Specified Human Drugs and Medical Devices
Report containing data on actions taken during CY 2020 related to inspections that were necessary for the approval of specified human drugs and medical devices - CY 2019 FDARA Section 902 Annual Report on Inspections: Facility Inspections Necessary to the Approval of Specified Human Drugs and Medical Devices
Report containing data on actions taken during CY 2019 related to inspections that were necessary for the approval of specified human drugs and medical devices. - CY 2018 FDARA Section 902 Annual Report on Inspections: Facility Inspections Necessary to the Approval of Specified Human Drugs and Medical Devices
Report containing data on actions taken during CY 2018 related to inspections that were necessary for the approval of specified human drugs and medical devices. - CY 2017 FDARA Section 902 Annual Report on Inspections: Facility Inspections Necessary to the Approval of Specified Human Drugs and Medical Devices
Report containing data on inspections conducted during CY 2017 that were necessary for the approval of specified human drugs and medical devices. (FDARA Section 902)
FDARA Section 903 Real Time Quarterly Reports
FDARA Section 903, focuses on streamlining and improving consistency in performance reporting and requires the FDA to provide Real Time reporting related to the process for the review of human drugs and biologics, medical devices, generic drugs, and biosimilar biological products.
- FY 2024 Q3 Real Time Report - Prescription Drugs (PDF - 530KB)
- FY 2023 Q4 Real Time Report - Prescription Drugs (PDF - 543KB)
- FY 2022 Q4 Real Time Report - Prescription Drugs (PDF - 391KB)
- FY 2021 Q4 Real Time Report - Prescription Drugs (PDF - 251KB)
- FY 2020 Q4 Real Time Report - Prescription Drugs (PDF - 113KB)
- FY 2019 Q4 Real Time Report - Prescription Drugs (PDF - 481KB)
- FY 2018 Q4 Real Time Report – Prescription Drugs (PDF - 118KB)
PDUFA - Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to the process for the review of human drug applications. (FDARA Section 903(a)) - FY 2024 Q3 Real Time Report - Devices (PDF - 423KB)
- FY 2023 Q4 Real Time Report - Devices (PDF - 599KB)
- FY 2022 Q4 Real Time Report - Devices (PDF - 417KB)
- FY 2021 Q4 Real Time Report - Devices (PDF - 317KB)
- FY 2020 Q4 Real Time Report - Devices (PDF - 584KB)
- FY 2019 Q4 Real Time Report – Devices (PDF - 471KB)
- FY 2018 Q4 Real Time Report – Devices (PDF - 142KB)
MDUFA - Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to the process for the review of devices. (FDARA Section 903(b)) - FY 2024 Q3 Real Time Report - Generic Drugs (PDF - 606KB)
- FY 2023 Q4 Real Time Report - Generic Drugs (PDF - 994KB)
- FY 2022 Q4 Real Time Report - Generic Drugs (PDF - 662KB)
- FY 2021 Q4 Real Time Report - Generic Drugs (PDF - 374KB)
- FY 2020 Q4 Real Time Report - Generic Drugs (PDF - 274 KB)
- FY 2019 Q4 Real Time Report – Generic Drugs (PDF - 442KB)
- FY 2018 Q4 Real Time Report – Generic Drugs (PDF - 246KB)
GDUFA - Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to human generic drug activities. (FDARA Section 903(c)) - FY 2024 Q3 Real Time Report - Biosimilars (PDF - 381KB)
- FY 2023 Q4 Real Time Report - Biosimilars (PDF - 369KB)
- FY 2022 Q4 Real Time Report - Biosimilars (PDF - 265KB)
- FY 2021 Q4 Real Time Report - Biosimilars (PDF - 440KB)
- FY 2020 Q4 Real Time Report - Biosimilars (PDF - 57KB)
- FY 2019 Q4 Real Time Report – Biosimilars (PDF - 221KB)
- FY 2018 Q4 Real Time Report – Biosimilars (PDF - 75KB)
BsUFA - Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to the process for the review of biosimilars. (FDARA Section 903(d))