May. 12 at 3:37 PM
$OTLK Dr. Sherman’s advice is firm and simple: “When in doubt, ask.”
Some sponsors burn time and goodwill trying to reverse-engineer what they think the FDA wants. That approach is a recipe for delays, additional review cycles, or even regulatory mistrust. “I can’t count the number of times a sponsor made a decision based on what they assumed we wanted. And I’d ask them—Why didn’t you just ask?”
