“Breakthrough” Flexibility: FDA Answers Industry Call On Manufacturing Data
This article was originally published in The Gold Sheet
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.
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CDER Director Woodcock was quickly consulted about a manufacturing concern at a foreign site that emerged shortly before FDA’s target action date for Novartis’ ceritinib NDA as the agency strove to avoid delaying approval of the “breakthrough” lung cancer therapy.
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.
Sponsors and FDA also will have to work through issues related to companion diagnostics to prevent treatments designated under the FDASIA’s new expedited development pathway from being delayed. Harmonization with foreign regulators is essential to making the pathway work, stakeholders say.