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.

Investigational New Drug (IND) Overview for a First-in-Human (FIH) Trial

The IND is an exemption from the Federal statute that prohibits an unapproved product intended for human use from being shipped in interstate commerce. The IND is the vehicle by which the sponsor obtains this exemption.

The information provided in the IND includes

  • Animal Pharmacology and Toxicology Studies
  • Chemistry, Manufacturing, and Control Data
  • Clinical Protocols and Investigator Information

The FDA has 30 days to review the IND from the date it is received. The sponsor will receive an acknowledgment letter from the FDA with the date the IND was received and when the IND will be active (i.e., when the first clinical trial can begin). During the 30-day review period, the FDA has an opportunity to review the IND for safety to ensure that subjects will not be exposed to unreasonable risks. If the FDA does not object, after the 30 days have elapsed or on earlier notification by the FDA, the first clinical trial may begin.