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US FDA’s Coronavirus Workload Shifting Beyond Idea Stage

 
• By Derrick Gingery

Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.

Coronavirus
The evolution of industry approaches to the pandemic is typical for situations where there is a critical needs for treatments quickly. • Source: Shutterstock

The Food and Drug Administration’s coronavirus workload appears to be transitioning to a new stage less focused on new and unproven ideas and more intent on confirming the promise of candidates further along the development timeline.

Launch of Phase III trials for coronavirus vaccines is a milestone in industry’s response to the pandemic, and the shift in focus has already been reflected the agency’s shifting workload. The FDA’s Coronavirus Treatment Acceleration Program (CTAP) reported that more than 230 trials had been reviewed for potential therapies, meaning INDs were determined as safe to proceed, as of 30 June. More than 510 drug development programs also were in the planning stages, which were active pre-INDs

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