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Primer On FDA’s "Breakthrough Therapy" Program

Executive Summary

A look at the genesis of the US expedited regulatory pathway for drugs and biologics, its benefits, and how the program is working today.

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Should You Request "Breakthrough" Status? Sponsors, FDA Give Their Advice

Companies need to be selective in seeking the designation and certain that they’ll be able to keep up with the accelerated pace of development and manufacturing expected under the expedited pathway.

FDA Offers Clues, But No Clear Standards, On "Breakthrough"-Worthiness

Although officials say “breakthrough therapies” are “transformative” treatments that “hit you in the face” with their efficacy, the agency has yet to release clear guidelines to help industry determine when a product is worthy of the coveted designation.

FDA Offers Clues, But No Clear Standards, On "Breakthrough"-Worthiness

Although officials say “breakthrough therapies” are “transformative” treatments that “hit you in the face” with their efficacy, the agency has yet to release clear guidelines to help industry determine when a product is worthy of the coveted designation.

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