US Drug Development: The IND Submission

The drug-development process in the US consists of several major steps. This section of the THinc website focuses on the first major step: the submission of an IND to the FDA to allow clinical testing. Following is an overview of the type of information that would support a typical first-in-human (FIH) clinical trial. Many factors impact the decisions made during the drug-development process and can affect the development time and strategies.