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“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Office of New Drugs director says the agency is seeing more small, inexperienced companies traveling the drug development and approval pathway on their own. However, these firms need more advice from the agency and are all too eager to publicly share their one-sided view about these regulatory interactions.

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