>>Mr. Tyler said such issues "can't handcuff the agency for all time" in reviewing a company's drug application.
Coming from the FDA Chief Counsel, that is an interesting statement. Note "for all time". That seems to admit that the allegation could delay an application.
Given that Janet Woodcock recused herself, any delay should have ended there.
Anyone know when she recused herself?
ij
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)