Director: Moheb
Nasr, Ph.D.
Acting Deputy Director:
Christine Moore, 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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