Zykadia Expedited Timeline Challenged By Late-Breaking GMP Concern
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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.
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Review Of Reviews: Drug Review Profiles 2014
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.
Same-Day BLA Filings Show Pfizer Has Gained Ground On Novartis In Meningitis B
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