FDA Upset Sponsor Did Not Submit IND Before Starting Trial

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FDA Issues Warning Letter to Sponsor for Allegedly Not Submitting IND Before Starting Clinical Trials

J.W. Schomisch

February 14, 2025 at 10:09 AM EST

The FDA’s Center for Drug Evaluation and Research sent a Feb. 4 Warning Letter to ISOThrive, Inc. in Healdsburg, Calif., for allegedly failing to submit an Investigational New Drug application (IND) for the conduct of clinical investigations with an investigational new drug that is subject to 21 C.F.R. §312.2(a). The letter said a Bioresearch Monitoring inspection conducted b... Read More

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FDA Issues Warning Letter to Sponsor for Allegedly Not Submitting IND Before Starting Clinical Trials

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