Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

FDA 52

FDA Compliance 52

Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. I also want to point out that neither Republicans nor Biden have yet said that they consider Medicaid in that same untouchable category.

US Department of Health and Human Services 52

US Department of Health and Human Services Medicare Medicare FDA 52

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. 2d 439 (2005): [A]t the time this [product] was sold, it complied with all safety standards. 3d 1245 (N.J. 2d at 1013-14. Beloit Corp. ,

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

JULY 13, 2023

When we have given talks on preemption, whether to law firm personnel, attendees of professional conferences, or new FDA employees, we have tended to start with the Supremacy Clause and then break up the types of preemption and the issues related to them into different buckets. The most famous of these is probably Bates v.

FDA 52

FDA 52