Essentials of RA: Rules for Writing a Regulatory Submission for Quick Approval

| 01 December 2008

This article provides several simple rules for writing a "good" regulatory submission that provides data to the regulators and quick approvals for industry. It includes views from both sides of the "submission fence"-an industry perspective on how to write a good submission and a regulator's perspective on what the manufacturer should include to accelerate the review process.

 

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