Senate Approves FDA User Fee Reauthorization Bill On 94-1 Vote
The Senate Aug. 3 swiftly approved the FDA Reauthorization Act (FDARA) on a 94-1 vote. The president is expected to sign the bill, which previously passed the House and will enact the MDUFA IV user-fee agreement and make reforms tied to device accessory review, device facility inspections, and medical imaging FDA reviews.
You may also be interested in...
MDUFA V: US FDA Staff Could See September Lay-Off Notices
The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.
Medtech-Supporter Sen. Al Franken To Resign, After Harassment Charges
Sen. Al Franken, D-Minn., who has championed key device regulatory reform changes favoring the medtech industry that are now law, will step down from his post, following newly revealed charges of sexual harassment by a former congressional staffer in 2006.
MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill
President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.