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

This article was originally published in RPM Report

Executive Summary

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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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.

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