Assignment Task: Describe the process for submitting an IND to initiate a clinical trial. When can a trial begin? Describe a clinical hold and the implications of such a hold on a development program as well as the process for getting the hold lifted. Describe key designations available to help expedite a development program (e.g. RMAT, Breakthrough Designation, Priority review, Priority Review Voucher); what are advantages of these designations, what impact may they have both pre and post approval, what impact would each have on development timelines? Need Assignment Help?