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New FDA guidance on addressing misinformation under White House review

Agency IQ

The new draft document comes as FDA leadership has been flagging concerns about misinformation, including in public testimony and reports. Fill out the form to read the full article.

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Senate hearing on hazardous substance listing for PFAS finds common ground, but disagreements on implementation tactics

Agency IQ

The testimony of witnesses and the Senators themselves largely agreed on the designation, but diverged on questions of liability exemptions. Fill out the form to read the full article. Per- and polyfluoroalkyl substances (PFAS) are a large class of synthetic fluorinated organic compounds.

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Article FDA Thank You In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue

Agency IQ

Under Article III of the Constitution , a party must have “standing” to challenge a rule or law. Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone,” the court wrote. None of these theories suffices to establish Article III standing,” the court added.

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Article FDA Thank You New FDA guidance on addressing misinformation under White House review

Agency IQ

The new draft document comes as FDA leadership has been flagging concerns about misinformation, including in public testimony and reports.

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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

Notably, he shared this information on his Twitter account, which was later scrubbed clean of his Tweets when Stephen Hahn took the helm of the agency, and is therefore no longer available ( see here for a Regulatory Focus article summarizing Gottlieb’s statements ). What happens in the longer term?

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Stand by Your Case? Without Standing, Supreme Court Precedent Means You’ll Have More Bad Times than Good

FDA Law Blog: Biosimilars

In alleging that antibiotic use was a public health problem that FDA should regulate, the plaintiffs offered several testimonials from ostensibly affected people. The causation of injury was too speculative, too indirect to support an actual case or controversy under Article III of the U.S. Constitution.

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Analysis Chemical Thank You Senate hearing on hazardous substance listing for PFAS finds common ground, but disagreements on implementation tactics

Agency IQ

The testimony of witnesses and the Senators themselves largely agreed on the designation, but diverged on questions of liability exemptions. Kenney testimony Kenney, New Mexico’s secretary of the environment, gave testimony focused on state implementation issues, particularly those faced by New Mexico. DEBBIE STABENOW (D-Mich.),