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This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.
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Rather, it “obligate[d] only the Secretary of Health and Human Services” to create “‘conditions designed to ensure’ informed consent.” Since the FDCA didn’t “impose any obligations” on anybody but the FDA, “it cannot conflict” with anything these defendants did or didn’t do. 555, 573 (2009), and these antivaxxers didn’t come close.
A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.
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