1. Pink Sheet

Off-Label Debate Between FDA, Industry To Formally Begin After Election

 
• By Michael Cipriano

After years of industry prodding, FDA schedules a two-day public meeting in November to establish direction for off-label regulation, but the agency is already being pulled in multiple directions.

FDA entrance sign 2016

Stakeholders applauded FDA's announcement that it would hold a two-day public hearing to gather input on off-label medical product issues, but they are already pulling the agency in several different directions in terms of a desired policy approach.

FDA is finally jumping into the minefield of off-label prescribing with its Nov. 9-10 meeting, following years of push from industry to establish a clear position

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