Behind The Approval Letter: Drug Review Profiles
A listing of the Drug Review Profile series articles published in the Pink Sheet.
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Regulatory framework for biosimilars is still a work in progress, especially on the analytical and labeling issues that featured in the Pink Sheet's Drug Review Profile of Zarxio.
FDA's worries about sufficiency of long-term safety data were exacerbated by 'weak' bridging data between two formulations; agency decided against refuse-to-file action but directed Amgen to immediately begin new PK/PD study.
Sanofi and Regeneron's 'extended negotiations' with FDA on requirements would later apply to Amgen's Repatha.