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

Drug & Device Law

JULY 24, 2023

2019) (“ PATDC82 I ”), because the third-party payor (“TPP”) plaintiffs were allowed to misuse RICO to pursue what was essentially a garden variety inadequate warning case – that the drug Actos increased the risk of bladder cancer. What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co.

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Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th 4th 1263 (9th Cir.

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Testimonials FDA Drugs Vaccine 105

Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. Doctors Who Perform Abortions: Their Characteristics & Patterns of Holding & Using Hospital Privileges,” 6.

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FDA Production FDA Approval Regulations 59