Following review of an initial IND application submission, Center for Drug Evaluation and Research (CDER) has 30-calendar-days in which to decide if a clinical hold is necessary Generally, the Drug Review Division does not contact the sponsor if no concerns arise with drug safety and the proposed clinical trials. The sponsor is notified about the deficiencies through a Clinical hold. A clinical hold is issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend a clinical investigation.