The Investigational New Drug (IND) application is a critical piece in getting a new therapy greenlighted for human clinical trials. To best inform the content of the IND, your clinical trial design, and have the agency address as many of your questions/concerns as possible prior to submission, sponsors are urged to request a Type B Pre-IND meeting with FDA. Submitting an application that meets and exceeds FDA requirements on the first attempt is essential to maintaining your drug development timeline.
Properly completing the IND application requires an in-depth understanding of all regulatory affairs and guidelines. Due to the large amount of data and supplemental information required for this application, it is not uncommon for missteps to occur on the sponsor’s side. Errors can take place in the IND preparation, authoring, and publishing phase which could delay drug advancement or potentially put a program on clinical hold.
Download our IND whitepaper on how to successfully navigate through the application process.