FDA Law Blog: Biosimilars

JULY 21, 2024

Alliance for Nurses started as a Citizen’s Petition back in 2016, making its way to District Court when FDA took no action. In alleging that antibiotic use was a public health problem that FDA should regulate, the plaintiffs offered several testimonials from ostensibly affected people.

Nurses 59

Nurses FDA Testimonials Doctors 59

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…. My dear old doctor told me that hormone testing is expensive and unnecessary…. My doctor said it was all simple math….

Production 52

Production Packaging Doctors Research 52

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.

FDA 40

FDA Doctors Testimonials Regulations 40

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.

Testimonials 52

Testimonials FDA Approval FDA Doctors 52

Drug & Device Law

FEBRUARY 11, 2024

On appeal, the Fifth Circuit overturned the District Court’s nullification of the FDA’s approvals of both branded and generic versions of mifepristone but affirmed that court’s voiding of both the 2016 risk evaluation and mitigation strategy (“REMS”) and 2021 non-enforcement decision that allowed telemedicine prescription of mifepristone.

FDA 59

FDA Production FDA Approval Regulations 59

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. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

OCTOBER 30, 2023

Notwithstanding a settlement in 2016, it’s still up and running, it appears. W]ith considerable testimony from their own experts that all of the plaintiffs fell within an acceptable range, they have failed to adduce competent evidence in support of their claims. Plaintiffs’ doctors were adequately and timely warned.

Testimonials 59

Testimonials Production Doctors Treatment 59