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Gendarmes & Responsibilities of the IND Sponsor Define what is meant by a sponsor Broad areas of sponsor responsibilities Describe the purpose of FDA Form 1571 and how to maintain an IND Elizabeth
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An IND sponsor is the individual or entity who is responsible for submitting an Investigational New Drug application to the FDA for approval to conduct clinical trials.
The IND sponsor is typically a pharmaceutical company, biotechnology firm, or researcher who is developing a new drug for human use.
The IND sponsor must fill out the required forms and submit them to the FDA, along with supporting documentation such as preclinical data and study protocols.
The purpose of the IND sponsor is to demonstrate to the FDA that the new drug is safe and effective for use in human clinical trials.
The IND sponsor must provide information about the drug's composition, manufacturing process, pharmacology, toxicology, and proposed clinical trial protocols.
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