Department of Health and Human Services February 19, 2008 – Federal Register Recent Federal Regulation Documents
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Memorandum of Understanding Between the Division of Select Agents and Toxins Center for Disease Control and Prevention and the Food and Drug Administration
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention (CDC). The purpose of this MOU is to establish a procedure to allow CDC/DSAT to confirm that FDA has accepted or approved, under the authority of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq), an Investigational New Drug application (IND), a request to establish an Investigational New Animal Drug file (INAD), or an Investigational Device Exemption application (IDE) for a clinical trial involving the use of an investigational product that is, bears, or contains a select agent or toxin.
Memorandum of Understanding Between the Walter Reed Army Institute for Research, the Food and Drug Administration, and the F. Edward Herbert School of Medicine of the Uniformed Services University of the Health Sciences
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Walter Reed Army Institute of Research, FDA, and the F. Edward Herbert School of Medicine of the Uniformed Services University of the Health Sciences. This MOU identifies the terms of collaboration between the three Federal entities in the coordination of the established Clinical Pharmacology Fellowship Training Program. Specifically, this collaboration provides for active duty Army, Air Force, Navy, and Public Health Service Medical Corps officers in the fellowship program to arrange a 2 to 4 month internship within FDA's Center for Drug Evaluation and Research (CDER) through CDER's Office of Clinical Pharmacology.
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