FDA gives guidance to sponsor-investigators

By CenterWatch
Published: March 2017

In May 2015, the FDA released a draft guidance designed to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This white paper defines sponsor-investigator-initiated trials, explains the rationale for increasing numbers of sponsor-investigator-initiated trials, describes the process for sponsor-investigators to submit an IND and discusses specific items a sponsor-investigator must include in an IND.

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