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“Breakthrough Therapy” Development Speed May Be Tempered By Manufacturing Hurdles

 
• By Sue Sutter

Sponsors and FDA also will have to work through issues related to companion diagnostics to prevent treatments designated under the FDASIA’s new expedited development pathway from being delayed. Harmonization with foreign regulators is essential to making the pathway work, stakeholders say.

The promise of an expedited development pathway for “breakthrough therapies” is potentially one of the biggest game-changers to come out of the FDA Safety and Innovation Act, and it has certainly generated excitement among FDA, industry and patient groups. But the promise of speeding innovative medicines to market could be blunted unless issues related to manufacturing, companion diagnostics and international harmonization are adequately addressed.

That was the message from a multi-stakeholder panel discussion at the Nov. 14 Conference on Clinical Cancer Research, co-sponsored by...

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More from North America

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

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