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Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments

Document ID: FDA-2013-N-0271-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2013-13083
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Details Information

Document Subtype: General Notice
Received Date: June 04 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 33421 - 33423
Page Count: 3
Comment Start Date: June 4 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 5 2013, at 11:59 PM Eastern Standard Time

Attachments:

Reference 1 The FDA as a Public Health Agency

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Reference 2 Earlier Sustained Virologic Response End Points for Regulatory Approval and Dose Selection of Hepatitis C Therapies

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Reference 3 Renal Biomarker Qualification Submission: A Dialog Between the FDA-EMEA and Predictive Safety Testing Consortium

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