The US Food and Drug Administration (FDA) has issued proposed advertising guidelines for drug and medical device manufacturers.
This draft guidance describes factors the FDA considers when evaluating advertisements and promotional labelling for drugs and medical devices.
The guidelines aren’t legally binding but do offer guidance on how to keep within FDA rules.
The guidelines discuss factors that are relevant to the disclosure of risk information and they provide numerous examples to illustrate the FDA’s thinking.
The move responds to stakeholder requests for specific guidance on how the FDA evaluates prescription drug and medical device promotional pieces to determine whether they adequately present risk information.
The recommendations contained in this draft guidance apply to promotional materials directed at consumers and healthcare professionals.