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Pazdur To Oncology Drug Developers: Step Back, Slow Down – And Find The Right Dose

 
• By Kate Rawson

FDA’s “Project Optimus” draft guidance on dose optimization is in the works. Until then, randomized dosing studies need to be an IND-level conversation.

Cancer cells on scientific background.3d illustration
Waiting to address dosing issues post approval will not be an option in the future. • Source: Shutterstock

 It may be time to start applying the brakes to oncology drug development.

Perhaps surprisingly, that’s the opinion of the US Food and Drug Administration’s Oncology Center of Excellence director Richard Pazdur. The breakthrough era of targeted oncology drugs has resulted in an...

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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
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