Plan B Headed For Behind-The-Counter Sale

FDA is understood to have decided to approve the emergency contraceptive as a new, third class of product, which would restrict access but not require a prescription.

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More from Pink Sheet

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

New EU Filings

 

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
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DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.