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U.S. Department of Health and Human Services

About FDA

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Welcome to the Office of New Drug Quality Assessment

Acting Director: Christine Moore, Ph.D.
Deputy Directors: Elaine Morefield, Ph.D.

10903 New Hampshire Avenue HFD-800
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: teshara.bouie@fda.hhs.gov

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