FDA Human Medical Product User Fee Programs (CRS Report for Congress)
Premium Purchase PDF for $24.95 (18 pages)
add to cart or
subscribe for unlimited access
Pro Premium subscribers have free access to our full library of CRS reports.
Subscribe today, or
request a demo to learn more.
| Release Date |
Revised April 26, 2024 |
| Report Number |
R44750 |
| Report Type |
Report |
| Authors |
Agata Dabrowska; Judith A. Johnson; Amanda K. Sarata; Susan Thaul |
| Source Agency |
Congressional Research Service |
| Older Revisions |
-
Premium Revised Sept. 27, 2021 (17 pages, $24.95)
add
-
Premium Revised Feb. 16, 2021 (17 pages, $24.95)
add
-
Premium Revised Nov. 21, 2017 (14 pages, $24.95)
add
-
Premium Revised Nov. 1, 2017 (14 pages, $24.95)
add
-
Premium Jan. 30, 2017 (14 pages, $24.95)
add
|
Summary:
Suppress; short paragraph provided with key terms to enable searching for this report:
The Food and Drug Administration (FDA) regulates human medical products to ensure they are safe and effective for their intended use in patients. Medical products include prescription and nonprescription (over-the-counter) drugs, biologics or biological products, and medical devices. FDA regulation of these products involves both premarket and postmarket regulatory requirements. The four user fee programs discussed in this report are prescription drugs, medical devices, generic drugs, and biosimilars. The Prescription Drug User Fee Act of 1992 (PDUFA, P.L. 102-571); The Medical Device User Fee and Modernization Act of 2002 (MDUFMA, P.L. 107-250) or MDUFA; The Generic Drug User Fee Amendments of 2012 (GDUFA, Title III of FDASIA, P.L. 112-144); The Biosimilar User Fee Act of 2012 (BsUFA, Title IV of the Food and Drug Administration Safety and Innovation Act [FDASIA], P.L. 112-144). The Food and Drug Administration Reauthorization Act of 2017 (FDARA, P.L. 115-52) continues the five-year reauthorization cycle of the human medical product user fee programs. Center for Biologics Evaluation and Research (CBER) regulates traditional biologics, such as vaccines. Center for Devices and Radiological Health (CDRH) regulates medical devices. Center for Drug Evaluation and Research (CDER) regulates prescription brand-name and generic drugs, over-the-counter drugs, and most therapeutic biologics.
