Must do a search on the web for clinical studies of investigational product which the FDA has put on a complete clinical hold. Once a clinical study of the students choice has been identified, the student must conduct a research on that particular sponsor, investigational product, and clinical study, and compose a meeting request to FDA regarding the clinical hold status.Read the FDA guidance document for meeting request for information regarding the items that are required for a meeting request.While creating a meeting request, there will be a number of items which is not accessible to you on the web (ie application number and list of individuals who will attend the meeting, etc.). In that case, please make up the number and names of the individuals and their titles.Your grade will be based on the quality of contents (clarity, conciseness, comprehensible), organization, writing proficiency (spelling, grammar, and punctuation), effective written communication (word usage), and adherence to the guidelines suggested.
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