FDA-TRACK: Drugs

 

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FDA-TRACK: CDER Dashboards

The Center for Drug Evaluation and Research (CDER) reports performance measures that highlight its involvement across the life cycle of a drug through policy and science development, pre-approval safety review, and post-approval safety monitoring.

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: PDUFA Performance

The Prescription Drug User Fee Act (PDUFA) authorizes FDA (specifically CDER and the Center for Biologics Evaluation and Research (CBER) 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: BsUFA Performance

The Biosimilar User Fee Act (BsUFA) authorizes FDA (specifically CDER and CBER) 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: 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: OMUFA Performance

The Over-The-Counter Monograph Drug User Fee Program (OMUFA) authorizes FDA (specifically CDER) 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). 

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.