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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.
Back to The New Drug Development Process
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