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A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics

 
• By Shirley Haley

FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA.

FDA is likely to be more accepting of off-the-shelf companion diagnostics for “breakthrough” therapies as it works out ways to move the diagnostic component through development at the same accelerated rate the breakthrough program affords drugs, stakeholders agreed during a June 25 panel discussion at the DIA annual meeting in Boston.

There have been indications that FDA will be flexible about use of an available CLIA (Clinical Lab Improvements Act) assay that does not have to go through the traditional diagnostic...

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