4 ms·
Is there a way to determine if FDA actually set this requirement for the study? Is it on public record? Or do we just have to rely on what they claim. Also why
by pkaye 3y ago
Is there a way to determine if FDA actually set this requirement for the study? Is it on public record? Or do we just have to rely on what they claim.
Also why not try getting it approved elsewhere first like in the EU if FDA is making it harder to approve?
- at_a_remove 3y agoI can only add that I wrote Dr. Hillman over a decade ago and he wasn't specific about it, only that the FDA's requirements were not reasonable.