Search Results for Office of Regulatory Affairs

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FDA Launches New ORA Structure to Align Inspections With Expertise By Michael Mezher - Published 15 May 2017

The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Program Alignment, Office of Regulatory Affairs, Inspections

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 Announces Major Regulatory Changes, With Specialization a Key Focus By Alexander Gaffney, RAC - Published 08 October 2014

Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Blood, Drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products

Tags: PAG, Program Alignment Group, ORA, Office of Regulatory Affairs, Regulatory Specialization, Regulatory Training, Regulatory Education

FDA Quietly Announces Creation of New Regulatory Division, Search Begins for Leader By Alexander Gaffney, RAC - Published 08 July 2014

The US Food and Drug Administration (FDA) is looking to hire a high-level regulatory official to lead the agency's brand new division of Regulatory Affairs Strategic Management (RASM), it announced this week.

Categories: News, US, FDA, Regulatory strategy

Tags: Office of Regulatory Affairs, DACRA SM, RASM, Regulatory Affairs Strategic Management, Deputy Assistant Commissioner