Search Results for House Energy

Showing 1 – 4

Cybersecurity: House Committee Looks to Build on Public-Private Partnerships By Michael Mezher - Published 04 April 2017

The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector.

Categories: News, US, FDA, Medical Devices

Tags: Cybersecurity, Information Sharing and Analysis Centers, ISACs, NH-ISAC, House Energy & Commerce

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: News, US, FDA, Compliance, Medical Devices

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

FDA Defends Plans to Regulate LDTs at House Hearing By Michael Mezher - Published 17 November 2015

The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs).

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Laboratory developed tests, LDTs, House Energy and Commerce Committee, E&C

BREAKING: Congress Seeks Dozens of Major Regulatory Reforms in New Bill By Alexander Gaffney, RAC - Published 27 January 2015

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.

Categories: News, US, CBER, CDER, CDRH, Advertising and Promotion, Biologics and biotechnology, Clinical, Drugs, In vitro diagnostics, Medical Devices, Orphan products, Submission and registration

Tags: 21st Century Cures Act, Congress, FDA Legislation, House, Energy and Commerce Committee