Biomedical Reform Legislation May Be Piecemeal But Holistic
This article was originally published in The Pink Sheet Daily
21st Century Cures Initiative – House Energy and Commerce Committee’s FDA, healthcare reform initiative – gets praise for its all-encompassing assessment of biomedical innovation process, but necessary legislative fixes may not come all at once.
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House Energy and Commerce committee says it’s committed to a bill to accelerate U.S. biomedical innovation before the next FDA user fee cycle, but the wide scope of needs and stakeholders may make crafting legislation challenging – never mind getting it passed.
Retiring after 40 years in Congress, Waxman leaves an enormous legacy, but also many recent legislative defeats.
Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues
Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.