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Complete Submissions Are Key To Good Review Management Principles – FDA

Executive Summary

As FDA rolls out its Good Review Management Principles - its attempt to improve FDA's timely review of drug applications through professional best practices - the agency is stressing the importance of sponsors submitting complete applications to facilitate this process

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Lessons Learned: New FDA Guidance On Meetings With Sponsors Adds Depth

FDA's new iteration of its guidance on meetings with sponsors reflects lessons learned during the surge in meeting requests the agency has had in the nine years since the original formal meetings final guidance was issued in February 2000

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