FDA-TRACK: User Fee Performance

 

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Human Medical Product User Fee Performance

PDUFA

The Prescription Drug User Fee Act (PDUFA) authorizes FDA to assess and collect fees for prescription drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities.

• Data Dashboards
• Performance Reports

BsUFA

The Biosimilar User Fee Act (BsUFA) authorizes FDA to assess and collect fees for biosimilar biological products. FDA dedicates these fees toward expediting the review process for biosimilar biological products. BsUFA facilitates the development of safe and effective biosimilar products for the American public.

• Data Dashboards
• Performance Reports

GDUFA

The Generic Drug User Fee Amendments (GDUFA) authorizes FDA to assess and collect fees for generic drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of generic human drug applications to ensure patients have access to safe, high-quality, and affordable generic drugs.

• Data Dashboards
• Performance Reports

MDUFA

The Medical Device User Fee Amendments (MDUFA) authorizes FDA to assess and collect fees for medical devices. MDUFA provides FDA with resources to increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.

• Data Dashboards
• Performance Reports

 

OMUFA

The Over-The-Counter Monograph Drug User Fee Program (OMUFA) authorizes FDA to assess and collect fees for FDA’s regulatory activities related to Over-The-Counter monograph drugs (e.g. antacids, acne medications, cough and cold products, sunscreens, and antiperspirants). 

• Data Dashboards
• Performance Reports

 

Animal Drug User Fee Performance

ADUFA

The Animal Drug User Fee Act (ADUFA) authorizes FDA to assess and collect fees for new animal drug products. ADUFA provides FDA with resources to enhance the performance and predictability of the new animal drug review process, resulting in the approval of safe and effective animal drug products.

AGDUFA

The Animal Generic Drug User Fee Act (AGDUFA) authorizes FDA to assess and collect fees for generic new animal drug products. AGDUFA provides FDA with resources to enhance the performance and predictability of the generic new animal drug review process, resulting in the approval of safe and effective animal drug products.

• Data Dashboards
• Performance Reports

• Data Dashboards
• Performance Reports