FDA’s Rx Promo Citations Rise Slightly In 2016; Investigational Drug Promos Scrutinized
Office of Prescription Drug Promotion seemed to expand its focus in issuing 11 letters last year.
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Biopharma sponsors should start with information that needs to be disclosed to satisfy SEC rules and understand how a press release will be used to avoid running afoul of agency regulations, industry exec says; company contracts with investigators also should set limits on what they can say about an unapproved drug.
Third enforcement letter of the year cites meeting exhibit and webpage that suggest crenolanib is safe and effective for an unapproved use.
Idelvion promotional materials misleadingly imply that patients can engage in high-risk activity without consequences; first letter from US biologics promo branch in three years.