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FDA releases drug trial snapshots

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The FDA has released Drug Trials Snapshots on its website. These snapshots look at the demographics of drug trial studies and present that information for patients and physicians to further help them interpret drug studies.

For example, one recent drug study had this race breakdown of participants:

ucm423554-420

Marketers should look up their own drugs and see what patients and HCPs will see about their indication and clinical studies.

Also from the FDA last week was draft guidance on “Providing Regulatory Submissions in Electronic and Non-Electronic Format–Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry“. This draft guidances reinforces that electronic media need to be submitted in a way that allows the FDA to experience the information. Sometimes still images are not enough and video or interactive electronic information should be considered. As we highlighted in our POV on the FDA draft guidance on social reporting, this can be just a link submitted to the agency on a monthly basis.

Source: FDA.gov

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