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 National Institutes of Health (NIH) Clinical Center (CC). It consists of elective rotations at the Office of Clinical Pharmacology (OCP) and the Office of New Drugs (OND) of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research. It is 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 CC 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. |
Type of Collaborative Activity: |
Training Initiative
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Year the Collaborative Activity Originated: |
2007 |
NIH Participating Institutes/Centers/Office of the Director: |
CC, NCI, NIAID, NIDCR, NIDDK, NIMH, NINDS |
HHS Agency Collaborators on this Activity: |
FDA |
