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FDA Issues Final Guidance on IND Requirement for Human Research Studies
02 December 2013
We are writing this memo to bring to your attention a guidance document on investigational new drug applications (INDs) that impacts the food industry. The Food and Drug Administration (FDA) published its final guidance: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND (IND Guidance).
The guidance was intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether an IND will be required for human studies with drugs. Regardless of its original intent, section D.2. “Conventional Food” of the final guidance, which was not included in the draft guidance FDA published in 2010, has imposed IND requirements on certain human studies with conventional food. The agency’s new policy has taken an unduly restrictive view of what constitutes food and poses great challenge for food companies sponsoring human studies. Our detailed analysis follows.
Click here to read more.
Authored by Martin Hahn and Xin Tao.
Washington, D.C.
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