A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Although it is up to sponsors and investigators whether to file an IND application, institutional review boards (IRB) still need to review those decisions, according to FDA draft guidance. In cases where the sponsor and investigator have decided not to file, the IRB should request documentation to substantiate the decision, such as a letter from the sponsor or the FDA. Drug Industry Daily