Presented by: Edward Basile
Presented by: Edward Basile
Presented by: Edward Basile
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PRE-APPROVAL PROMOTION<br />
• FDA prohibits pre-approval promotion of an<br />
investigational biologic or drug. 21 C.F.R. §<br />
312.7(a).<br />
• Failure to adhere to § 312.7(a) is a violation of the<br />
IND regulations and can result in termination of<br />
the IND or other FDA enforcement action. 21<br />
C.F.R. § 312.44(b)(1)(v) and (2)(1).<br />
• Promotion of an investigational device is<br />
prohibited, and subjects the violator to FDA<br />
enforcement action. 21 C.F.R. § 812.7
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