Preparing an IND submission: Here is what drug sponsors should anticipate 

[Photo by Chokniti Khongchum on Pexels:]

Before drug sponsors can conduct clinical trials of new therapeutics in the U.S., they must first receive permission from the FDA. The vehicle by which that permission is sought is an Investigational New Drug (IND) application, and once it is submitted, drug development effectively ceases until regulators approve it. The main goal of an IND submission is to present regulators with data that supports a product’s safety for use in humans.

The FDA’s Center for Drug Evaluation and Research (CDER) reviews each application within 30 days. CDER looks for evidence that study participants will avoid “unreasonable risk of significant illness or injury” during early clinical trials and that the study is designed to meet its objectives. INDs that fail to support safety claims adequately can be placed o…

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