Three years of market exclusivity following an Rx-to-OTC switch might not be enough of an incentive to encourage manufacturers to apply for switches, former FDA Nonprescription Drugs Advisory Committee chair Randy Juhl, PhD, University of Pittsburgh, suggested at the American Pharmaceutical Association annual meeting March 11.
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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.’
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.
The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.
