FDA Response Time For DTC Ad Advisory Comments Has Doubled, Agency Says
FDA has increased from two to four weeks the time it takes to return direct-to-consumer broadcast ads with advisory comments due to the enlarged volume of submissions, Division of Drug Marketing, Advertising & Communications Branch Chief Nancy Ostrove, PhD, reported Sept. 13 at a Food & Drug Law Institute conference on "Marketing and Promotion in the New Millennium."
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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