RNA-LNP Regulatory Considerations

Recommendations for Investigational New Drug (IND) Approval

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


For a successful IND filing, starting with the end in mind allows researchers to make wise decisions about scaling and production processes during each development phase to streamline the overall process. By identifying clinical goals at the outset, developers can establish preclinical programs that generate supporting data and manufacturing strategies at each stage, strengthening the IND filing and accelerating the path to clinical development.