Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 94

FDA Reauthorization Act (FDARA) was signed into law on August 18, 2017 and it extended the user fee programs for drugs, medical devices, generic drugs, and biosimilar biological products through FY 2022 (and added other obligations). It reauthorized PDUFA for the fifth time. In addition, the Medical Device User Fee Amendments (MDUFA) was reauthorized for the third time, and included both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time.

Selected provisions of FDARA include the following:

An enhanced ability to capture patient preferences in drug development;

Flexibility to inspect medical device facilities based on risk, while encouraging predictability and transparency in the inspection process;

A focus on treatment of rare diseases (especially in pediatrics);

Additional resources for review of breakthrough therapies;

“Real world evidence” to inform decision-making (including use of the Sentinel System);

Enhanced partnerships with patients;

More flexibility in the regulatory pathway for certain medical device accessories;

New opportunities for scientific advice on surrogate endpoints;

Cross-center coordination of combination product review;

Enhanced hiring and retention of well-qualified staff.

Bottom line: The reauthorization of PDUFA, MDUFA, GDUFA, and BsUFA support FDA’s organizational ability to focus on improved health outcomes while promoting biomedical innovation.