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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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Posted 27 January 2015 | By Alexander Gaffney, RAC,
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:
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.
Tags: 21st Century Cures Act, Congress, FDA Legislation, House, Energy and Commerce Committee
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