FDA Draft Guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion, 5/09

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In May 2009, the CDER, CBER, CDRH, and CVM published the draft FDA guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotions for public review and comment.ﾠ

This draft guidance describes the factors that theﾠ FDA considers when evaluating advertisements (ads) and ﾠpromotional labeling for prescription drugs, ads for restricted medical devices, and promotional labelingﾠfor all medical devices.ﾠInternet web sites promoting these products are also within scope. The draft guidance discusses factors that are relevant to theﾠdisclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors.

Web site designers and builders will want to review section III.C.2., Non-Print Promotion, for specific design requirements.

UPDATE: As of late 2015, a final version of this guidance document had not yet been published