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.’
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
