If FDA decides to incorporate mandatory prescriber training into a Risk Evaluation and Mitigation Strategy for extended-release opioids, industry implementation options include setting up an industry-wide registry or seeking congressional action to tie training verification into a Drug Enforcement Administration registry
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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 Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
