The mission of the Office of Clinical
Pharmacology (OCP) is to
assure the safety and effectiveness of new
drugs through the evaluation of clinical
pharmacology and biopharmaceutics data in
support of the Center for Drug Evaluation and
Research's Investigational New Drug (IND) and
New Drug Application (NDA) review programs. Through research, we assure that regulatory
policy and decision making are based on the
best available science.
OCP's activities include:
- Conducting reviews of pre-IND data, INDs,
end of phase 2 data, pre-NDA data, NDAs, and
NDA supplements to determine:
- what are the most relevant clinical
issues
- what effect does clinical pharmacology
have on dosing
- what issues will have an impact on the
drug's labeling
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