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  1. Office of Medical Products and Tobacco

Office of New Drug Quality Assessment

ONDQA is now reorganized and realigned to the new
Office of Pharmaceutical Quality

 

Sarah Pope Miksinski, Ph.D., Acting Director
Scott Furness, Ph.D., Deputy Director for Review and Operations
Ramesh K. Sood, Ph.D., Acting Deputy Director for Science and Policy
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-1900      Fax: (301) 796-9748

 

Description

Overview:

The Office of New Drug Quality Assessment (ONDQA) assesses the critical quality attributes and manufacturing processes of new drugs, establishes quality standards to assure safety and efficacy, and facilitates new drug development. The Office of New Drug Quality Assessment focuses on critical pharmaceutical quality attributes (chemistry, pharmaceutical formulation, stability, manufacturing processes, bioavailability, product performance) and their relevance to safety and efficacy. ONDQA emphasizes quality by design in the evaluation of critical aspects of pharmaceutical quality; has a strong focus on manufacturing science; integrates review and inspection functions; and uses modern statistical methodologies.

Mission:

ONDQA assesses the critical quality attributes and manufacturing processes of new drugs, establishes quality standards to assure safety and efficacy, and facilitates new drug development.

Vision:

ONDQA is a strong scientific organization that serves CDER, FDA, and the public through leadership in innovation and international collaboration.

Please feel free to send questions or comments to: stephen.moore@fda.hhs.gov