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What Not To Do: FDA Reviewer Talks Cancer Drug Development Mistakes

 
• By Emily Hayes

Using anonymous examples at the recent AACR meeting, FDA’s Tatiana Prowell highlights mistakes made and lessons learned in oncology drug reviews.

SAN DIEGO — Failure to identify the right dose prior to approval, neglect of patient-reported outcomes and a rush to beat competitors are among the common drug development mistakes flagged at a major cancer research meeting by FDA official Tatiana Prowell.

“When I ask people: ‘What’s your rush?’ Mostly I hear, ‘Well it’s where our competitors are,’” said Prowell, scientific lead...

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More from North America

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