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Title of Collaborative Activity:

Reciprocal Educational and Training Partnerships between FDA/CDER and the NIH Clinical Center

Description of Collaborative Activity:

This activity is sponsored by the Clinical Pharmacology Program, Office of Clinical Research Training and Medical Education (OCRTME) at the NIH Clinical Center and it consists of elective rotations at the Office of Clinical Pharmacology (OCP) and the Office of New Drugs (OND)- FDA/CDER for NIH staff with a primary focus on clinical fellows and research fellows who expressed an interest in learning more about FDA regulatory sciences applicable to drug development research. Rotating fellows are mentored by FDA staff on the required elements of an Investigational New Drug (IND) application and the key elements of the FDA review process from a regulatory perspective. This program also established a mechanism for FDA scientific reviewers at the OCP to rotate at the NIH Clinical Center and to interact with members of a clinical research team, thus acquiring a better perspective on clinical research protocol implementation and the requirements of an Institutional Review Board (IRB) at the NIH.

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