A bipartisan amendment to user fee legislation offers a softer approach to addressing "right to try" concerns related to experimental pharmaceuticals that could defuse the issue during the current session of Congress.
Expanded Access Amendment Could Blunt 'Right To Try' Legislation In US
Senate's user fee legislation would now require FDA and NIH to hold a public meeting about how to broaden clinical trial enrollment; amendment offers a more subtle approach to increase access to experimental treatments than does 'right-to-try legislation.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.