The HIV/AIDS vaccine researchers' orientation to the process of preparing a USFDA application for an investigational new drug (IND): what it is all about and how you start by preparing for your pre-IND meeting

摘要

Despite numerous government publications, review articles and book chapters, talks at conferences, and even an international association of "regulatory affairs" consultants what to do to get permission from the US FDA to test a new drug or vaccine remains a mystery to most academic scientists. Many investigators waste far too much time before contacting the FDA because they worry the requirements will be too onerous and others that do contact the FDA get sent a ton of documents (to "help" in filling out an IND application) most of which are unfortunately too long and tedious to be helpful or encouraging. This article provides "user friendly" help to get HIV/AIDS vaccine scientists acquainted with the IND application process. It is broken down into topical sections with a question and answer format, and much of the more technical information and asides have been separated out into appendices and footnotes in an attempt to make it easier to digest. But enough introduction! The first and biggest mistake, that costs most investigators the most in development time, is putting off starting the process of getting an IND. So let us get to work.