An IND is a request for FDA authorization to administer an investigational drug or biological product to humans. The application must show results of preclinical experiments, if applicable; the chemical structure of the compound; how it is thought to work in the body; any side effects found in animal studies; and how the compound is manufactured (chemistry, manufacturing and controls section). The IND must also include a detailed clinical trial plan, including how, where and by whom the studies will be conducted. Based on the information of the IND application, the FDA will determine if there is sufficient evidence to support initial human testing. The sponsor must wait 30 days after submitting the IND to the FDA for review. At the end of the 30 day review period, unless the FDA identifies a potential safety problem involving the use of the drug and asks for a delay, the sponsor may begin the proposed clinical testing.
The Office for Research Protections Quality Assurance Program can help investigators apply for an IND. Contact them at orp-qm@psu.edu.