Investigational New Drug Applications (INDs)
Similar to an Investigation Device Exemption (IDE), which is submitted to the FDA prior to beginning clinical trials of a medical device, the Investigational New Drug (IND) application is intended to provide sufficient data to the FDA to demonstrate that it is reasonable to begin clinical tests of a new drug or biologic product on humans. The IND is the means through which the sponsor technically obtains exemption from FDA regulations governing the interstate commerce of drug and biologic products while they are under clinical investigation.
During a new product'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 product exhibits early safety and effectiveness that suggest an opportunity for 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.
The Investigational New Drug Application (IND)is not an application for marketing approval. The IND is a submission in which the sponsor provides a summary of the preclinical testing from in vitro and in vivo methods and a summary of the manufacturing and control methods that will be used to produce the clinical product. The IND also contains the details of the clinical investigation plan.
MDCI helps clients with combination products, such as drug/device and biologic/device applications in which the primary mode of action is either the drug or biologic component, and correspondingly, the FDA Center for Drugs (CDER) or Center for Biologics (CBER) will have primary jurisdiction. MDCI can help clients identify how their particular product will likely be regulated by FDA, and facilitate the preparation of IND documentation for agency review.
Contact us today to learn how we can help with your IND Application.
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Device Regulatory Guidance
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