FDA-TRACK: Congressional and Industry Performance

 

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OCP

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.

• Data Dashboards
• Performance Reports

Annual Reports on Inspections of Establishments

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.

• Data Dashboards
• Performance Reports

FDARA Section 902 Annual Report on Inspections

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.

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.

• Data Dashboards
• Performance Reports

• Data Dashboards
• Performance Reports