Collaboration Details

Title of Collaborative Activity:

FDA Clinical Pharmacology Review Rotation

Description of Collaborative Activity:

The fellow typically completes a 6 week rotation at the FDA in the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER). The fellow participates in the review of INDs and supplemental NDAs, including the evaluation of new clinical PK protocols, study reports etc. The fellow will take the lead on 1-2 key assignments, representing clinical pharmacology in interdisciplinary team meetings and writing the final clinical pharmacology report.

Type of Collaborative Activity:

Select Type of Collaborative Activity

Year the Collaborative Activity Originated:

2005

NIH Participating Institutes/Centers/Office of the Director:

CC

HHS Agency Collaborators on this Activity:

FDA