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Post marketing requirements and commitments are studies and clinical trials that sponsors conduct after product approval to gather additional information about a product's safety, efficacy or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conduct. Additional information about Post Marketing Requirements (PMR) and Post Marketing Commitments (PMC) can be found on the FDA Web site.
UCB is committed to ensuring patient safety and transparency of our PMR and PMC obligations. UCB provides the FDA with annual reports on the status of any study conducted pursuant to a PMR or PMC, until the requirement or commitment is fulfilled. Information about these PMR or PMC studies can be found on the FDA searchable Web site which is updated quarterly. UCB studies on the FDA Web site can be accessed by clicking on the link below and inserting "UCB" in the Applicant field of the search form.