Though Nik Modi, tobacco analyst for RBC Capital Markets, New York, describes FDA regulations as a notoriously “lengthy process,” 2017 marked a flurry of activity from the agency, including updates to existing regulations, a new director with a new direction and a slew of Advance Notices of Proposed Rulemaking (ANPRM). All of this followed a very busy 2016, during which the FDA dropped the final version of its long-awaited deeming rules and rejected the first modified risk tobacco product (MRTP) application accepted for consideration.
Given the escalation in recent years, 2018 stands to be the busiest year to date in terms of FDA regulations. But before the ball drops and ushers in the new year, here’s a look at the biggest federal stories of 2017.