Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Government shutdown: At present, the U.S. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

JUNE 16, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Government shutdown: At present, the FDA has appropriated funding through January 19. FDA finalized a ban on these devices in 2020, but the D.C. Circuit vacated the final rule in 2021.

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Drug & Device Law

FEBRUARY 16, 2024

Plaintiffs included in their motion for reconsideration a lengthy affidavit contending that the court’s decision dismissing their failure to warn claim was based on the wrong physician’s testimony. If accepted, the testimony may have altered the court’s analysis in the second motion for summary judgment. Allied Mut.

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Testimonials FDA Approval FDA Doctors 52

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. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v.

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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. They excluded bogus expert testimony under Fed. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

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