Pink Sheet Podcast: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes

 
• By Derrick Gingery, Sarah Karlin-Smith, and Bridget Silverman

Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August, a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi, and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews.

Pink Sheet podcast
Could EMA requiring raw clinical data for application reviews boost global harmonization efforts? • Source: Citeline/Shutterstock

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