A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics
Executive Summary
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.
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Agency says the amount of regulatory leeway given on CMC data requirements will take into account such factors as seriousness of the condition and robustness of the sponsor’s quality system.
“Breakthrough” Flexibility: FDA Answers Industry Call On Manufacturing Data
Agency says the amount of regulatory leeway given on CMC data requirements will take into account such factors as seriousness of the condition and robustness of the sponsor’s quality system.
Breakthroughs for Patients, CMC Regulatory Flexibility
By compressing clinical timelines, a FDASIA-mandated “breakthrough therapy” application process is pressuring FDA and industry to complete CMC reviews much more quickly. While FDA is emphasizing starting earlier and working harder, industry is talking more about the possibility of deferring some CMC activities post-submission or post-approval.