When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic. Under the FDA’s Clinical Data Summary Pilot Program, transparency of the approval process and access to more study-related documents are the goals, according to FDA commissioner Scott Gottlieb, M.D. who released a statement on 16 January 2018 about the new pilot program.