Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the guidances was a Final Rule regarding tobacco products and their regulation. Several Industry groups banded together and submitted a Citizen’s Petition to the FDA, requesting a stay of the rule. This article outlines the regulation, the petition, and the FDA’s response.