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  5. FDA Reauthorization Act of 2017 (FDARA)
  6. Reports and Plans Mandated by FDARA
  1. Selected Amendments to the FD&C Act

Reports and Plans Mandated by FDARA

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.

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 902 Annual Report on Inspections

FDARA Section 902 requires FDA to post calendar year information related to inspections of facilities necessary for the approval of specified human drugs and medical devices.

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.