Office of Clinical Pharmacology (OCP)

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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