FDA stresses importance of act that affirms USA as 'leader in biomedical innovation'

While the signing of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) was not the the action of US President Donald Trump that garnered most headlines last week, it has undoubted importance for the drug development industry.

This act, which allows the FDA to continue to collect medical product user fees through fiscal year 2022, was passed by Congress and signed into law by Mr Trump on Friday.

The act reauthorized the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time.