Memorandum of Understanding Between the Division of Select Agents and Toxins Center for Disease Control and Prevention and the Food and Drug Administration
Agency: Department of Health and Human Services Volume: 73, Number: 33 Date: 2008-02-19 Related link
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.
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