FDA is considering omitting the space needed for a properly sized Uniform Product Code symbol from the calculation of whether an OTC package is exempt from the type size requirements of the OTC labeling final rule, FDA ODE V Deputy Director Debra Bowen, MD, and Division of OTC Drugs Director Charles Ganley, MD, said at an OTC labeling "feedback" meeting in Rockville, Md. June 29.
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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.’
Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Rezdiffra, Madrigal Pharmaceuticals’s treatment for metabolic dysfunction-associated steatohepatitis.
The UK’s medicines regulator wants to ensure that guidance on the use of artificial intelligence in pharmacovigilance processes remains fit for the future.
