Senate Budget Draft Would Be Less Generous To US FDA Than House For FY2023
Senate appropriations bill would take back some of increase House offered Center for Drug Evaluation and Research and other FDA programs, setting up negotiations as start of FY2023 nears.
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Senate Appropriations Committee proposes $1.185bn to CFSAN and $2.19bn to CDER, both levels short of House appropriators passed in June. FDA requested $30.36m in user fees from monograph drugs but no amount was specified in Senate draft bill.
Company is coming into its second panel meeting with new data analyses from the CENTAUR trial, advisory committee experience under its belt, and a recent Health Canada approval. In an interview with the Pink Sheet, co-CEOs Cohen and Klee highlight clinical outcomes data with AMX0035 and say they are not too worried about the lack of effect on neurofilament biomarker.
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.