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PRODUCT: LUCEMYRA (Lofexidine) SUBJECT INFORMATION AND CONSENT FORM AND AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION IN CLINICAL RESEARCH PROTOCOL NUMBER: USWMLX130031SPONSOR: USAM,
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The sponsor of Lucemyra (lofexidine) is the pharmaceutical company that developed the drug, which is Indivior Inc.
The sponsor, which is typically the manufacturer or marketer of the drug, is required to file information related to Lucemyra.
The sponsor must complete the required forms provided by regulatory agencies, detailing the product information, clinical data, and compliance with regulations.
The purpose of the sponsor is to ensure the drug is developed, manufactured, and marketed according to legal and regulatory standards, including safety and efficacy.
The information that must be reported includes product labeling, clinical trial results, manufacturing processes, adverse event data, and marketing strategies.
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