Investigational New Drug (IND)

In Detail

An Investigational New Drug (IND) application is a formal request to the FDA for permission to begin testing a new drug or biologic in human subjects. The IND must be filed and allowed to proceed before any clinical trial can start in the United States. The application includes three main components: animal pharmacology and toxicology studies that demonstrate the drug's safety profile in preclinical testing, manufacturing information that shows the drug can be consistently produced with adequate quality, and a detailed clinical protocol describing the planned Phase 1 study, including objectives, design, participant selection criteria, and safety monitoring plans. The FDA has 30 days to review an IND application. If the agency does not object within that window (called a "clinical hold"), the sponsor may proceed with the proposed clinical trial. The FDA can place a clinical hold on the IND if there are safety concerns, if the trial design is inadequate, or if the investigators are not qualified. Once an IND is active, the sponsor must submit annual reports to the FDA summarizing the progress of all clinical studies conducted under the IND, as well as expedited safety reports for any serious adverse events. The IND remains active throughout all phases of clinical testing until the drug is either approved, the sponsor withdraws the application, or the FDA terminates it. An IND can also be filed for new uses of already-approved drugs. The IND process is a critical regulatory checkpoint that ensures human testing does not begin until there is sufficient evidence of safety from preclinical studies.