WASHINGTON—The U.S. House of Representatives Wednesday passed the Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the FDA’s drug and device reviews.
"We commend the House for passing the bipartisan Food and Drug Administration Safety and Innovation Act," said Allan Coukell, director of medical programs at the Pew Health Group. "This legislation will help deliver safe, effective and innovative medical products to patients. We also commend the Energy and Commerce Committee for its leadership throughout this process. We look forward to the bill’s passage through the U.S. Senate."
Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
More infoPew sent a comment letter to the Senate Committee on Health, Education, Labor and Pensions on the Pharmaceutical Compounding Quality and Accountability Act. This bill takes steps toward clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities—specifically, the compounding of sterile medicines that are shipped interstate.
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