Rx-to-OTC switch sponsors will be expected to work with FDA to establish predefined endpoints for each consumer behavior trial they plan, if the agency follows advice given by the Nonprescription Drugs Advisory Committee during a Sept. 25 meeting
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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 plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.
Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
