For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/aan4seyc/release/3 The Food and Drug Administration (FDA)’s primary objective is to ensure safety. Investigational New Drugs (INDs) are focused mainly on safety, and therefore, if applicable, preclinical toxicology, manufacturing, and pharmacology data are very important. Take advantage of the FDA’s accelerated programs, where applicable, to expedite commercialization. Engage with the FDA early on to guide your development program and develop relationships with the FDA. Consider global opportunities and plan ahead to meet relevant health authority regulations. Academic institutions can offer guidance and regulatory support to faculty investigators.