A fresh look at DTC: CDER's Division of Drug Marketing, Advertising & Communication is creating a second direct-to-consumer review group to address the ad division's growing review burden. "It's just important to try to address the increased workload that we're getting and to have two group leaders to help to make sure that our advisory comments to you are not getting bottlenecked somewhere," DTC Review Group Leader Melissa Moncavage says at FDLI's Sept. 18-19 advertising and promotion conference. The DTC review groups will be led by Moncavage and Lead Consumer Safety Officer Christine Smith, effective immediately. DDMAC will retain its four review groups to evaluate professional advertising. Funding to help meet DDMAC's workload, which has increased with the PhRMA guideline's recommendation for DTC preclearance, has come up in PDUFA negotiations...
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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.’
European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
