FDA New Year’s Resolution: Guidances On Payor Communications, Biosimilarity

Agency expects to issue 101 guidances in 2017, including those on REMS assessment, refusal to file NDA and BLA submissions, and amendments to ANDAs.

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...