December 1, 2023

Getting your investigational drug regulatory ready

Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators will want to see a purposeful plan to assess drug safety, quality, and efficacy over time. In this article, we outline some basic information and helpful strategies to facilitate efficient drug review.

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Tags: regulatory, IND, FDA, compliance