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Accelerating Drug Approval: Integrating FDA Processes with Operation Warp Speed

This resolution aims to speed up access to new drugs and biological products, such as vaccines. Citizens can expect faster market availability of innovative therapies, potentially improving treatment access and public health protection. These changes are intended to streamline approval processes, reducing the waiting time for new medical solutions.
Key points
Integrating Operation Warp Speed processes into Food and Drug Administration (FDA) operations to accelerate drug approval.
Issuing guidance to help speed up the development and approval of new drugs and biological products.
Utilizing existing safety and scientific data from already approved products for faster evaluation of new ones.
Collecting interim data during trials to allow for parallel assessment and simultaneous approval of multiple drugs.
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Additional Information
Print number: 117_HRES_876
Sponsor: Rep. Burgess, Michael C. [R-TX-26]
Process start date: 2022-01-19