The latest follow-up to the Age-Related Eye Diseases Study continues to show "beneficial effects" of antioxidants and zinc as therapy for age-related macular degeneration, according to Emily Y. Chew, the study chairwoman at the National Eye Institute
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The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
