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BioPharmaceutical United States Regulation

IND Sponsors Should Not Contact FDA Reviewers Directly, Draft Guidance Asserts

This article was originally published in The Pink Sheet Daily

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Executive Summary

Industry has pressed for more latitude on communications with agency, but FDA emphasizes that review division regulatory project managers should be primary contact.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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