Richard Burr: “Would you find it unacceptable if, in fact, the system was not providing what the health care professional prescribed to…”

If you can take the outline you just presented to me and get somebody from the Administration to fill in in between the action steps that are going to be taken, you might have a plan.

It is time that we hold the FDA accountable.

Ms. Kotagal's refusal to continue these common-sense measures speaks volumes of her lack of commitment to due process and transparency.

What does it mean for a small company when FDA misses these goals, and what does it mean to patients?