Firms Ask If DDMAC Will Assess Early Promo Claims Under TPP Guidance
• By Jamie Hammon
FDA's draft guidance directing sponsors to present proposed promotional claims in a "Target Product Profile" at the beginning of the drug development process does not address how the Division of Drug Marketing, Advertising, and Communications would be involved in the process
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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