Congress passes FDA Reauthorization Act (FDARA) of 2017

A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes was passed by the Congress on August 3, 2017. The federal budget process occurs in two stages:

1. appropriations, which set overall spending limits by agency or program, and
2. Authorizations, which direct how federal funds should (or should not) be used.

Appropriation and authorization provisions are typically made for single fiscal years. A reauthorization bill like this one renews the authorizations of an expiring law.

This new legislation reauthorizes the user fee programs necessary for the continued support of the agency’s pre-market evaluation of prescription drugs, medical devices, generic drugs, and biosimilar products. The bill reauthorized the below user fees through the fiscal year 2022

1. Prescription Drug User Fee Amendments of 2017
2. Medical Device User Fee Amendments of 2017
3. Generic Drug User Fee Amendments of 2017
4. Biosimilar User Fee Amendments of 2017

The timely reauthorization of these programs ensures continuity for our medical product review programs and is crucial to supporting our mission of protecting and promoting public health.

For more information about the bill and act please visit S. 934: FDA Reauthorization Act of 2017

 

 

? For any questions or comments or your regulatory requirement please email to [email protected] or use our contact form.