Agency IQ

JUNE 17, 2024

In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue Two lower courts had articulated a Rube Goldberg-esque theory of “standing” – the right of a person or organization to sue another entity – based on the idea that doctors not prescribing mifepristone or treating patients who had taken it had experienced economic harms.

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FDA Doctors Testimonials Regulations 40

The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. That took me through the dark underbelly of the multi-billion dollar weight loss industry controlled by government and elite societies….

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Production Packaging Doctors Research 52

Drug & Device Law

JANUARY 24, 2022

Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Valsartan Testimony ¶3. PPI ¶11 (participants must “comply with any government law, regulation or guidance regarding public health and safety during the COVID-19 pandemic”). All depositions. . . H/C ¶1(A); accord Zantac ¶22. Onglyza , ¶3; H/C ¶1(E).

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Pharmaceuticals Testimonials Trials Production 111

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. Polansky v. 3d 239 (Cal.

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Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” That testimony was contrary, not only to the common-law cases discussed in our prior posts , but also flatly contradicted §801.109(c). 801.109(c). Bard, Inc. ,

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Testimonials Licensing Licensing FDA 59