FDA Center for Drug Evaluation and Research’s 2017 guidance to-do list includes many of the items the agency had planned to get off its plate last year, including two of the most anticipated documents – guidances on biosimilar interchangeability and industry communications with payors.
The guidance agenda for calendar year 2017 includes 101 new and revised draft guidances. FDA posted the agenda on its website Jan. 11 and the following day issued two of the guidances on the list, questions and answers for 180-day exclusivity for abbreviated new drug application filers and guidance for multiple endpoints in clinical trials
