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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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.
A look at the genesis of the US expedited regulatory pathway for drugs and biologics, its benefits, and how the program is working today.
Pharmaceutical manufacturers and FDA have enthusiastically embraced the “breakthrough therapy” program as a way to more quickly bring new drugs with substantial effects to patients in need. With two years of program experience now under their belts, agency and industry representatives talk about learnings and best practices that could be applied to the development and review of drugs outside the program.