Or should we call it “22nd Century Cures?”
From the article:
Bio-world was buzzing this holiday weekend over whether this would be the week Congress finalized the 21st Century Cures Act.
Still iffy on that.
The House is scheduled to vote Wednesday on the $6.3 billion legislation, which would streamline approval of new drugs and devices, boost federal financing of medical research, and increase FDA’s budget by $500 million.
Legislators told STAT’s Sheila Kaplan, however, that negotiations are still ongoing.
Rachel Sachs, a health law expert from Washington University of St. Louis, penned a blog that’s being widely circulated on the implications of the 996-page draft. Her takeaway? Lawmakers have deleted controversial provisions that encouraged smaller clinical trials of medical devices and outsourced some device review. But they're risking a clash with the FDA by expanding the priority review voucher program.
Read the full article.