House Republicans want to dramatically overhaul the Food and Drug Administration’s (FDA) regulation of prescription drugs and medical devices, tripling patent protection for brand-name drugs, stripping detailed safety information from promotional materials, cutting some of the red tape in clinical trials, and expediting approval of medical devices. The 400-page draft bill, known as the 21st Century Cures Initiative, comes after nine months of meetings from both parties on the House Energy and Commerce Committee. The guidance is designed to modernize FDA oversight of drugs and medical devices, and regulations. While both parties offered input, most of the priorities come from ... Read More
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