JL- I understand it's harsh, but something is seriously wrong with the FDA's scheme of drug approval that needs the attention of Congress. I am sick of politicians skirting these issues as was the case when Senate HELP let the FDA off on SPA guidance Regulations. Additionally the FDA doesn't have the charter or brains to approve standards of care...to not keep pace with the standards of care is a SERIOUS PUBLIC SAFETY CONCERN that should be immediately attended to. WTF has Senators Baldwins office been up to these past 6 years besides not heeding my warnings? What a bunch of idiots...JMO.
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