U.S. Investigational New Drug Application → IND Application Process

Timeline of IND Application
Once an IND is submitted, the FDA has 30 days to review the IND application. Once the drug company has waited the 30 days after submitting, they are able to commence clinical trials. The FDA does not typically send a letter notifying the sponsor of approval. The FDA can put a complete or partial clinical hold on a study. A clinical hold means the study cannot proceed pending resolution of questions or concerns. The partial hold allows a part of the study to proceed while another part cannot be started. Once the sponsor-investigator responds to the FDA’s concerns, the FDA will issue a letter lifting the clinical hold and the study may proceed, place a partial hold on the study, or continue the clinical hold pending resolution of continued questions. There is no time limit on the clinical hold, though; the study may not proceed until the clinical hold is lifted by the FDA.