BREAKING: Congress Seeks Dozens of Major Regulatory Reforms in New Bill

Regulatory News

The US House of Representatives' Energy and Commerce (E&C) Committee today released a long-anticipated discussion draft of its 21st Century Cures Act, an ambitious attempt to overhaul the way the US Food and Drug Administration (FDA) regulates new healthcare products in the hopes of incentivizing the creation of new products to treat patients.

The 393-page draft contains five main sections, as well as dozens of subtitles:

• Title I—Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process And Addressing Unmet Needs
• Title II—Building The Foundation For 21st Century Medicine, Including Helping Young Scientists
• Title III—Modernizing Clinical Trials
• Title IV—Accelerating The Discovery, Development, And Delivery Cycle And Continuing 21st Century Innovation At NIH, FDA, CDC, And CMS
• Title V—Modernizing Medical Product Regulation

Regulatory Focus will have an update tomorrow explaining some of the bill's major provisions. For insight and analysis into all FDA-related legislation, please see our tracker here.