The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One – Part 2

The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One Part 2: Planning for the Meeting(s) Part 1 of “The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One” covered how to tell if – and when – to request a Q-Sub meeting, including whether […]

The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One – Part 1

The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One Part 1: Timing considerations Jim Kasic, Founder & Chairman, Boulder iQ Ah. The Q-Sub. The FDA loves Q-Sub meetings, manufacturers love to get FDA input and they’re free. What’s the issue? There is no issue – when product developers use […]