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