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FDA reauthorization bill clears final legislative hurdle, heads to president’s desk

Author: [none given]


A Food and Drug Administration (FDA) reauthorization bill approved by the Senate last week outlines faster approval of generic drugs, reforms to clinical trials, removal of barriers to pediatric cancer research and reauthorization of medical product user fee programs.

The FDA Reauthorization Act (FDARA), H.R. 2430 cleared the Senate with bipartisan support. The measure will next advance to the president’s desk for consideration.

U.S. Reps. Greg Walden (R-OR), Frank Pallone, Jr., (D-NJ), Michael Burgess (R-TX) and Gene Green (D-TX), all leaders of the House Energy and Commerce Committee, lauded the Senate’s bipartisan support of the bill.

“Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach,” the lawmakers said in a joint statement. “This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies. We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”

FDARA would reauthorize medical product user fee programs that help stymie foreign competition for U.S. medical device and biopharmaceutical developers while supporting the development of new drugs and therapies. The Generic Drug User Fee Amendments (GDUFA), the Biosimilar user Fee Act (SUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Amendments (MDUFA) were among those approved.

Life Science Daily,

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