Tag Archives: NIH

Capitol Hill Healthcare Update

Senate Panel OKs FDA User Fees Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after the Memorial Day recess. The Senate HELP Committee approved the five-year renewal on a 21-2 vote. … Continue Reading

Capitol Hill Healthcare Update

AHCA Autopsy: What Happened, What’s Next? House Speaker Paul Ryan’s decision to cancel Friday’s vote on the American Health Care Act triggered post-mortem jockeying among vying GOP factions struggling to come to grips with how the party failed to repeal a law it has singularly campaigned against for the last seven years. Republicans’ inability to … Continue Reading

More Time to Streamline: NIH Extends Deadline for Implementation of Single IRBs for Funded Studies

The research community has a full plate as it sifts through the final rule on the Common Rule issued last week. Many are now fully appreciating the December gift from the National Institutes of Health that granted an extension for developing policies to streamline multi-site studies under a single Institutional Review Board (IRB). On December … Continue Reading

21st Century Cures: Ambitious Medical Innovation Bill Has Broad Focus

In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century Cures Act. Championed over the past three years by bill sponsor and House Energy and Commerce Committee Chairman Fred Upton (R-MI), the Cures Act primarily overhauls the FDA’s drug and device … Continue Reading

Capitol Hill Healthcare Update

House Oks “Cures,” Senate Votes This Week The Senate this week is likely to give final congressional approval to legislation that adds billions of dollars for biomedical research and aims to speed the discovery and development of new drugs and medical devices. The “21st Century Cures” legislation won House approval last week 392-26. Although several … Continue Reading

Capitol Hill Healthcare Update

Congress Adjourns, Eyes Election Then Lame Duck Congress completed work last week on a stopgap budget that keeps the government open until a post-election lame-duck voting session in December, when lawmakers are expected to move on legislation dealing with medical innovation, mental health reform and possibly efforts to stop CMS’s proposed Medicare Part B drug … Continue Reading
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