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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

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

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FDA Vaccine Advisors Put Manufacturers On Notice: New Flu Vax Licensing Requirements May Be Coming

The US FDA and its vaccine advisors said manufacturers need to start thinking about the types of studies needed if a major change is made to the quadrivalent flu vaccine by swapping out the B/Yamagata lineage for a second lineage of another flu strain. 

It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

Podcast: Diversity, Equity, and Inclusion Measures Continue to Evolve in the Clinical Space

Listen to expert perspectives from Tracey Parker, Vice President, Biometrics, Advanced Clinical and Rebecca Starkie, Senior Global Patient Engagement Director, Advanced Clinical on the recent history of DEI in clinical trials and the barriers to patient participation. Examine the key drivers that have influenced the development of diversity, equity, and inclusion programs for clinical trials.

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