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This message was posted by a user wishing to remain anonymous Regardless of whether your clinical trial has any participants, IF it's been submitted to your IND it may be a good idea include it under on-going studied but mention that as of the data lock ...

The way an FDA auditor explained this to me was labels for uncleared/approved by FDA may not interfere with the health choices of any patient, either perceived or real possible treatment. If a patient has a disease and sees an ad for a non FDA approved ...

Forgot to mention the additional insights given by section 201(n) of the Act.  It (my paraphrase) says that, if an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising ...

The ANON reply was correct, CMC is required to be submitted outside the annual report.  Please see this link: IND Application Reporting: Annual Reports | FDA Here is the required info in the IND annual report with a 1571 cover page from that link: ...

Great question; thanks for circling back. FDA's approach to regulating website representations of a subject device that isn't cleared, approved, or otherwise legally marketed for the U.S. jurisdiction, is governed by U.S. medical device misbranding law. ...