FDA's final rule on OTC labeling "appears to be based on unrealistic assumptions," Consumer Healthcare Products Association Senior VP and Director of Science & Technology William Soller, PhD, asserted at an FDA "feedback" meeting April 23. "A number of examples used by FDA" as samples of OTC labels "are unrealistic projections of actual labeling," Soller added.
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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 inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.
