Infographic: US FDA IND Procedures – Regulatory Assistance
Current US law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The IND is the means through which the sponsor technically obtains this exemption from the FDA.
During a new drug’s early preclinical development, the sponsor’s primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
Asphalion and EXTEDO provide you with a series of infographics on the regulatory requirements in different regions. This infographic is focused on INDs for US FDA.
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