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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

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Valeant's Siliq Clears FDA Panel But Faces Prospect Of Post-Marketing Registry

Agency's advisors were divided on whether Valeant's proposal for voluntary registry would suffice or whether mandatory program under REMS was needed to better assess risk of suicide and suicidal behavior with psoriasis drug.

Korea Should Pursue Two-Pronged Strategy In Global Vaccine Hub Bid

South Korea is making a strategic push to strengthen its vaccine capabilities, with a focus on COVID-19 and future pandemics and the aim of becoming a global development hub. But one expert told a recent meeting that these goals should not overshadow the government’s original aim of becoming self-sufficient for the national immunization program.

Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular

The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.

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