I think it falls well outside the space that we are here to talk about today, but indeed it is a problem and it is a problem that leads us then to the FDA and to other areas that need examination by this committee and other committees.
Burr acknowledges the drug shortage issue's relevance to FDA and committee discussions.
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Ms. Kotagal's refusal to continue these common-sense measures speaks volumes of her lack of commitment to due process and transparency.
Why did FDA agree, and why did the industry agree to longer review times of 128 days on 510(k)'s and provide the agency with so much more money?
Are you beginning to see the pattern as to why a plan is important? This has been a well-orchestrated event up to this point.
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