Search Results for Program Alignment

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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 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