FDA-TRACK: Biologics

FDA-TRACK: CBER Dashboards

The Center for Biologics Evaluation and Research (CBER) reports performance measures that track progress towards the Center's strategic goals outlined in the 2021-2025 Strategic Plan.

FDA-TRACK: FDARA Section 903 Real Time Quarterly Performance

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.

FDA-TRACK: BsUFA Performance

The Biosimilar User Fee Act (BsUFA) authorizes FDA (specifically CBER and the Center for Drug Evaluation and Research (CDER)) 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.

FDA-TRACK: PDUFA Performance

The Prescription Drug User Fee Act (PDUFA) authorizes FDA (specifically CBER and CDER) 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.

FDA-TRACK: GDUFA Performance

The Generic Drug User Fee Amendments (GDUFA) authorizes FDA (specifically CBER and CDER) 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.

FDA-TRACK: MDUFA Performance

The Medical Device User Fee Amendments (MDUFA) authorizes FDA (specifically CBER and the Center for Devices and Radiological Health (CDRH)) 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.

FDA-TRACK: OCP Performance

The Medical Device User Fee and Modernization Act (MDUFMA) requires the HHS Secretary to submit an annual report to Congress on the activities and impact of the Office of Combination Products (OCP). The report focuses on OCP’s efforts to ensure the prompt assignment of combination products to agency centers, timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of combination products.

FDA-TRACK: Inspections of Establishments Performance

Section 705 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to publish annual reports on inspections of establishments registered under section 510 of the FD&C Act. Establishments registered under Section 510 of the FD&C Act engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs, human biologics regulated as drugs, and devices.

FDA-TRACK: FDARA Section 902 Inspections Performance

Section 902 of the FDA Reauthorization Act (FDARA) requires FDA to publish annual reports on inspections of facilities necessary for approval of a drug or a device conducted during the previous fiscal year.