The "Bad Ad" program already has proven to be a great success in motivating health care providers to report well-known forms of false or misleading drug promotion, such as ads that overstate efficacy and minimize risks, but can it help address more subtle and difficult-to-detect forms of questionable drug promotion, such as those that are hidden in drugmakers' support of professional education and clinical trials?
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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.’
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
