FDA’s Promotional Assessments Reorganized Around Specialty, Not Target Audience
This article was originally published in The Pink Sheet Daily
The two divisions within the Office of Prescription Drug Promotion are renamed the divisions of advertising and promotion review I and II; they will each have four teams operating within them in a structure akin to the Office of New Drugs.
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Office of Prescription Drug Promotion letters post-Caronia fail to cite off-label promotion, in contrast to previous years when about one-third to one-half of warning and untitled letters scolded companies for off-label violations.
The agency’s draft guidance on prereview of television advertisements also requires companies to submit the information they rely on to support claims in an ad.
The Division of Drug, Advertising, Marketing and Communications will consist of an office with two divisions, one to review materials for healthcare professionals and other to review direct-to-consumer promotions.