Xeris Biopharma Holdings, Inc.

Sponsors should review longstanding US Food and Drug Administration concepts on consumer-friendly language and claims limitations, and Office of Prescription Drug Promotion research priorities and enf

Despite the paucity of enforcement letters objecting to prescription drug promotions, the US Food and Drug Administration has shown concern about one aspect of advertisements: efficacy claims that are

The US Food and Drug Administration’s Office of Prescription Drug Promotion issued untitled letters to Evofem Biosciences, Inc. and Otsuka Pharmaceutical Development and Commercialization Inc. objec

Footnotes and statements below graphics cannot absolve the problems raised by misleading claims in an promotional piece, the US Food and Drug Administration told AstraZeneca PLC in a rare warning le