August 21, 2017
President Donald J. Trump recently signed the FDA Reauthorization Act of 2017 into law.
The FDA Reauthorization Act of 2017 (H.R. 2430) reauthorizes the user fee programs for prescription drugs, medical devices, generic drugs and biosimilars, and amends FDA authorities and activities related to medical products. The user fees, which are paid by manufacturers of drugs and medical devices, account for $8 billion to $9 billion during a period of 5 years. The law includes the Generic Drug User Fee Amendments, the Biosimilar User Fee Act, the Prescription Drug User Fee Act and the Medical Device User Fee Amendments, which must be reauthorized by Sept. 30.