FDA Relies On Experience To Judge Firazyr Self-Administration
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The Center for Devices and Radiological Health recommended a delay in approving Firazyr until a human factors study could be conducted to rule out risks associated with the self-administration device, but CDER reviewers concluded that experience with the device in clinical trials and real life was sufficient to demonstrate safety.
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Regulatory Round-Up: Drug Review Profiles From 2012
Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.
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