Drug Developers Ask For Flexible Combinations In Co-Development Regulation
Drug makers responding to FDA's draft guidance on co-development of novel drugs to be used in combination asked the agency to loosen up the boundaries on what kinds of products can be combined, particularly in light of the requirement that the products be aimed only at serious and life-threatening diseases for which there are no satisfactory alternatives.
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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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