Office of Regulatory Affairs

FDA Guideline to Inspection of Validation of Cleaning Processes, Office of Regulatory Affairs, July 1993... 

US FDA, ITG subject bacterial endotoxins/pyrogens. In Office of Regulatory Affairs (Ed.), Inspector s Technical Guide, Washington, DC, 1987. 

Office of Regulatory Affairs, Conditions Under Which Homeopathic Drugs May Be Marketed, CPG 7132.15, Sec. 400.400, FDA, Rockville, MD, Revised March 1995. 

Office of Regulatory Affairs. Guide To Inspections Of Quality FDA, RockviUe,... 

Evaluation and Research (CDER), Office of Regulatory Affairs (ORA) and the Center for Veterinary Medicine (CVM), which was titled the PAT initiative. 

Lynch, Kara, Deputy Director, Team Biologies, Office of Regional Operations, Office of Regulatory Affairs, OC, FDA, July 11, 2001. 

Office of Regulatory Affairs, Food and Drug Administration, Rockville, Maryland, U.S.A. 

The FDA district offices operate under the auspices of the agency s Office of Regulatory Affairs (ORA). The ORA field organization is divided into five regional offices (northeast, central, southeast, southwest, Pacific). Each region includes district offices, of which there are 20 nationwide. Most district offices have three or four branches, including either a compliance branch or an enforcement branch. The branch offices are the primary regulatory contacts within the districts and act as the eyes and ears for FDA headquarters. 

The guidance specifies the application information that should be provided to the Center for Drug Evaluation and Research (CDER) to ensure continuing product quality and performance chacteristics of the sernisolid topical formulation for specified changes. The guidance does not comment on or otherwise affect compliance/inspection documentation defined by the Office of Compliance in CDER or the Office of Regulatory Affairs at FDA. 

Office of Regulatory Affairs of the Food and Drug Administration and the National Center for T oxicological Research, Computerized Data Systems for Nonclinical Safety Assessment, October 11,1987. 

U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Bioresearch Monitoring (BIMO), Good Laboratory Practice, Compliance Program 7348.808. 

Office of Regulatory Affairs, Food and Drug Administration Guide to Inspection of Pharmaceutical Quality Control Laboratories, July 1993 Website http //www.fda.gov/ora/inspect ref/igs/pharm.html. 

Compliance References. This Web site from the Office of Regulatory Affairs provides links to compliance policy guides, regulatory procedures... 

Regulatory Affairs The FDA s Office of Regulatory Affairs is increasingly active in international standards activities relevant to quality control and conforming assessment, including activities relevant to ISO—9001 and laboratory regulation. 

Compliance Policy Guides are FDA internal documents that provide precedent for GMP (and other) enforcement decisions by FDA s field offices. They are found on the Field Operations or ORA (Office of Regulatory Affairs) pages on FDA s website under the heading Compliance References. ... 

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