Study Ongoing

Once CDER's 30-day initial review period expires, clinical studies can be initiated, unless a clinical hold has been placed. Beyond the 30-day review period for an IND, subsequent clinical trials may begin immediately upon submission of the clinical protocol to the IND (i.e., there is no 30-day waiting period for subsequent clinical trials after the submission of the first clinical trial protocol). If the sponsor was notified of deficiencies that were not serious enough to warrant a clinical hold, the sponsor addresses these deficiencies while the study proceeds.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.