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OFF-LABEL PROMOTION IS UNLIKELY TO PROVIDE INFORMATION BENEFIT TO PHYSICIANS, FDA's TEMPLE SAYS; SINGLE PIVOTAL STUDIES ARE "NOT CHEAPER" AND "HIGH RISK"
A relaxation of FDA's prohibition on the promotion of off-label uses of pharmaceuticals is unlikely to improve the practice of medicine, FDA Office of Drug Evaluation I Director Robert Temple, MD, contended during the Third Annual Princeton Drug Development Conference in Princeton, N.J. May 5.
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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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Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
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If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
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Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.