Thirty Day Wait For Initial

The FDA must have time to review an initial IND before the investigational drug is shipped and the first clinical investigation is initiated. This review time is essential to protect the public health because the FDA must assure that, based on the evidence presented in the initial IND, it is reasonable to proceed with the first proposed clinical investigation. The more specific nature of the FDA's review is described in a separate section below. The 30-day review clock begins on the day of the FDA's receipt of the initial IND, not on the day the sponsor mails the application. Thirty days after the FDA receives the IND, unless the FDA has notified the sponsor that the proposed clinical investigation is subject to a clinical hold, the IND becomes effective and the first proposed clinical investigation may be initiated. The sponsor may not send or deliver the investigational drug to any investigator named in the IND until the IND has become effective (unless the FDA has authorized otherwise).

The reader should note that the FDA does not ''approve'' INDs; rather, the FDA allows acceptable INDs to come into effect so that human investigations can proceed. The regulations do not require an active step with verbal or written notification by the FDA to the sponsor so that the sponsor is notified that the IND is in effect. By default, the IND goes into effect 30 days after the FDA receives it, assuming that no clinical hold has been imposed. Many sponsors, as well as divisions of the FDA, are uncomfortable with this passive aspect of the regulations. These sponsors and divisions typically rely on teleconferences to learn verbally whether the FDA will allow the IND to come into effect.

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