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Regulatory Affairs Part I: The IND Phase and Part II: The NDA Phase November 1518, 2010, Baltimore, MD, USA Enrollment limited to 50 registrants. Basics of Regulatory Affairs from the IND to the NDA
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Part I Form IND is the section of the Investigational New Drug Application (IND) form that provides the necessary information about the sponsor's contact details, the investigational drug, and the clinical trial plan.
Sponsors or applicants who intend to conduct clinical trials on investigational new drugs are required to file Part I Form IND with the FDA.
Part I Form IND can be filled out by providing accurate and complete information about the sponsor, the investigational drug, and the clinical trial plan as per the FDA guidelines.
The purpose of Part I Form IND is to provide the FDA with essential information about the investigational new drug, the sponsor, and the planned clinical trial in order to assess the safety and effectiveness of the drug.
Part I Form IND must include information such as the sponsor's contact details, the investigational drug's composition and manufacturing details, and the proposed clinical trial protocol.
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