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Office of Regulatory Affairs

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Office Profile

Comprehensive profile of Office of Regulatory Affairs, including its role, location, and regulatory activities.

People (10)
Mark W. Jackson
FDA_ASSOCIATED_PERSON
Nichole B. Murphy
FDA_ASSOCIATED_PERSON
Lareese K. Thomas
FDA_ASSOCIATED_PERSON
Lisa M. Althar
FDA_ASSOCIATED_PERSON
Bruce I. Skolnick
FDA_ASSOCIATED_PERSON
Haba cuc V. Barrera
FDA_ASSOCIATED_PERSON
Anthony N. Onianwa
FDA_ASSOCIATED_PERSON
Bary H. Phillipes
FDA_ASSOCIATED_PERSON
Arie C. Menachem
FDA_ASSOCIATED_PERSON
Justine M. Corson
FDA_ASSOCIATED_PERSON
Records (20)
483 - Core Health and Fitness, LLC

other • July 30, 2026

483
483 - Infinite Biomedical Technologies

device • July 30, 2026

483
483 - Lentigen Technology, Inc.

drugs • June 24, 2026

483
483 - University of Virginia Health System

drugs • June 18, 2026

483
483 - Granules Pharmaceuticals Inc.

drugs • April 3, 2026

483
483 - Automated Ophthalmics, Inc.

device • February 13, 2026

483
483 - Bioreliance Corporation

other • January 29, 2026

483
483 - Mylan, Inc. A Viatris Company

drugs • December 22, 2025

483
483 - Washington Fertility Center

biologics • October 23, 2025

483
483 - INOVA Health Care Services Blood Donor Services

biologics • September 25, 2025

483
483 - Noble Life Sciences, Inc

other • June 20, 2025

483
483 - Jubilant Cadista Pharmaceuticals, Inc.

drugs • January 15, 2025

483
EIR - InnoStar Bio-Tech Nantong Company, Ltd.

drugs • November 1, 2024

EIR
483 - Lexington Medical Center

biologics • October 30, 2024

483
483 - QuVa Pharma, Inc.

Devices • October 28, 2024

483
483 - Tailstorm Health INC

Biologics • October 10, 2024

483
483 - RC Outsourcing, LLC

September 27, 2024

483
483 - Spok, Inc.

other • July 19, 2024

483
483 - Chesapeake Medical Products, Inc.

device • July 12, 2024

483
483 - Washington DC Veterans Affairs Medical Center

biologics • July 8, 2024

483

Showing 1 to 20 of 20 records

Guidance Documents (10)
CHAPTER 48 - 7348809 Bioresearch Monitoring
Guidance
FMD-145 - Release of the Establishment Inspection Report (EIR)
Guidance
CPG Sec 651100 Ethylenediamine Dihydroiodide (EDDI)
Guidance
CPG Sec 635100 Large Volume Parenterals (LVPs) for Animal Use
Guidance
CPG Sec 666100 Alternate Feeding of Different Medicated Feeds
Guidance
CPG Sec 608200 Prescription Use of Certain Injectable Animal Drugs
Guidance
CPG Sec 653100 Animal Grooming Aids
Guidance
CPG Sec 683100 Action Levels for Aflatoxins in Animal Feeds
Guidance
CPG Sec 665300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds
Guidance
Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C : Guidance for Industry and FDA Staff
Guidance
Related Offices (5)
Office of Compliance Intervention and Consultation
OCIC
Acting Division Director
Bureau of Environmental Health
Division of Nonprescription Drug Products
Division of Reproductive and Urologic Products
Office Information

Name

Office of Regulatory Affairs

Abbreviation

ORA

Country

USA

Postal Code

21117

State/Province

Maryland

City

Owings Mills

Dependent Locality

Address

11155 Dolfield Boulevard, Suite 117

Office Website

Visit Website

ID: ff91c598-cf72-4dbe-a2c8-7519c64cbc64

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
info@keypedia.com
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