Knocked Down But Not Out: Recovering From a Refuse to File
This article was originally published in RPM Report
Executive Summary
A "refusal-to-file" letter typically signals the end of a product's chances of ever getting approved in the US. Some companies, though, have returned from regulatory purgatory to get a review--and even approvals--after meeting FDA's demands.
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FDA's Great(er) Expectations: Avoiding a Refuse-to-File in a New Review Environment
Each year, FDA rejects just a handful of new drug and biologics applications that aren’t quite complete enough for review. Now the agency’s revamped review process is forcing its staff to take a closer, earlier look at new submissions. Merck’s Zetia/Lipitor "refuse to file" letter is a case in point. Unless things improve, Office of New Drugs Director John Jenkins says, industry can expect more early rejections from FDA.
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Each year, FDA rejects just a handful of new drug and biologics applications that aren’t quite complete enough for review. Now the agency’s revamped review process is forcing its staff to take a closer, earlier look at new submissions. Merck’s Zetia/Lipitor "refuse to file" letter is a case in point. Unless things improve, Office of New Drugs Director John Jenkins says, industry can expect more early rejections from FDA.
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