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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.

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.

FDA's Next-Generation Review Process: Avoiding the "Crisis Mentality"

There are changes coming to FDA's drug review process that, over the long term, should make the system more predictable and increase the chances for a first-cycle approval. Until then, expect a less forgiving agency when it comes to incomplete submissions-and challenges that may threaten the sanctity of priority reviews.

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