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Office of the Commissioner

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Office Profile

Comprehensive profile of Office of the Commissioner, including its role, location, and regulatory activities.

People (10)
Damon A. Growl
FDA_ASSOCIATED_PERSON
Dianne H. Milazzo
FDA_ASSOCIATED_PERSON
Grant D. Jones
FDA_ASSOCIATED_PERSON
Addam S. Reynolds
FDA_ASSOCIATED_PERSON
Teby Hill
FDA_ASSOCIATED_PERSON
Latorie S. Jones
FDA_ASSOCIATED_PERSON
Joseph R. Strelnik
FDA_ASSOCIATED_PERSON
Allison Bonnenburg
FDA_ASSOCIATED_PERSON
Roseline N. Boateng
FDA_ASSOCIATED_PERSON
Janet A. Rajan
FDA_ASSOCIATED_PERSON
Records (20)
RESUME - Unknown Company

Unknown Date

RESUME
483 - Hetero Labs Limited, Unit-IX

other • September 26, 2025

483
483 - Hetero Labs Limited (Warehouse)

other • September 23, 2025

483
483 - Cohance Lifesciences Limited

other • August 12, 2025

483
483 - Telix IsoTherapeutics Group, Inc.

other • July 31, 2025

483
483 - Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

other • July 11, 2025

483
483 - Alk-abello, Inc.

other • June 13, 2025

483
483 - ZOLL Medical Corporation

other • April 15, 2025

483
483 - TruAbutment Inc.

other • January 21, 2025

483
483 - BioMarin Pharmaceuticals, Inc.

other • December 13, 2024

483
483 - ANI Pharmaceuticals Inc

other • December 6, 2024

483
483 - Valentine Enterprises, Inc.

other • October 10, 2024

483
483 - ESTABLISHMENT LABS SA

other • July 24, 2024

483
483 - Aurobindo Pharma USA Inc

other • June 15, 2024

483
483 - Clean Solutions LLC

other • May 5, 2024

483
483 - Nana Barseghian, M.D.

other • February 16, 2024

483
483 - Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)

other • January 12, 2024

483
483 - Ucla Medical Ctr

December 18, 2015

483
483 - Medtronic Puerto Rico Operations Company

other • March 11, 2011

483
EIR - SriSai Biopharmaceutical Solutions LLC

Drugs • September 24, 2010

EIR

Showing 1 to 20 of 20 records

Guidance Documents (10)
Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry
Guidance
Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry
Guidance
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications: Guidance for Industry, IRBs, and Clinical Investigators
Guidance
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry, IRBs, and Clinical Investigators
Guidance
Cancer Clinical Trial Eligibility Criteria: Performance Status: Guidance for Industry, IRBs, and Clinical Investigators
Guidance
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry
Guidance
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft Guidance
Guidance
FDA Records Access Authority for Cosmetic Products: Draft Guidance for Industry
Guidance
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry
Guidance
QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry
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 the Commissioner

Abbreviation

OC

Country

USA

Postal Code

20993

State/Province

Maryland

City

Silver Spring

Address

10903 New Hampshire Avenue, WO66-5521

Office Website

Visit Website

ID: 79483979-9582-427f-ac3d-46c715811424

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Brooklyn, NY 11201
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Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
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🇪🇺+48 532-447-507
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