Zykadia Expedited Timeline Challenged By Late-Breaking GMP Concern
This article was originally published in The Gold Sheet
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.
You may also be interested in...
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.
Faced with the prospects of FDA non-approval of its priority review hepatitis C drug sofosbuvir, Gilead withdrew a foreign API manufacturer and one of its own testing facilities from the NDA late in the review process due to Good Manufacturing Practice violations and data integrity concerns.
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.