White Paper

Boost Regulatory Confidence: Recommendations For Investigational New Drug (IND) Approval

GettyImages-950086574 drug development

Before conducting clinical trials on cutting-edge novel medicines, pharmaceutical companies must successfully file regulatory documentation. Submitting an Investigational New Drug (IND) application for RNA therapeutics to the FDA is a significant milestone.

The IND application process must be meticulous and adhere to the rules; failing to gather and report the necessary chemical, manufacturing, and control (CMC) data and process specifics may prevent the IND from being approved. For successful IND submissions, it is critical to conduct general studies to evaluate the toxic effects of the new drug at various doses over specific periods.

The existing regulatory system is ambiguous for RNA therapeutics, so it is crucial to prepare early for regulatory filing that matches the rapid development of this new and rapidly evolving class of medicines. Leverage this IND guide to help accelerate and strengthen the IND filing of novel nanomedicines.

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