Special Protocol Assessment Draft Guidance Adds Biosimilars, Not Much Clarity
This article was originally published in The Pink Sheet Daily
SPA can be terminated by 'substantial scientific issue,' FDA tells industry, but notes that it only happens less than one percent of the time.
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More companies are turning to CDER’s formal appeals process when presented with a review division’s regulatory decision or advice. Even though few appeals are granted in full, many sponsors get valuable clarity on a path forward; some appeals, like that for Amarin’s Vascepa SPA, are turned away at the door.
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.