User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments
Executive Summary
Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.
You may also be interested in...
PDUFA Collections Exceeded Target In FY 2021, While GDUFA Fell Short
The US FDA reports that the prescription drug user fee program met 27 of its 29 commitments by the end of FY 2021 and the biosimilar user fee program is on track to meet 16 of 27 of its performance enhancement goals.
Rx Import Legislation: One Step Forward, Two Steps Back – And Odd Dance Partners
The strange politics of prescription drug importation legislation in the US are on display again, this time in the context of the FDA user fee reauthorization bill. Including the topic in the bill is a ‘big deal’ – but probably makes imports less likely.
US FDA Accelerated Approval Council Required Under Senate User Fee Bill
Intra-agency group would be tasked with ensuring consistent use of the expedited pathway across the FDA, with duties potentially including development of best practices, product review team training, and advising on withdrawals, according to the Senate's bipartisan user fee legislation.