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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 for breast cancer in FDA’s Office of Hematology and Oncology...

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More from United States

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

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