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.

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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. Janssen Pharmaceuticals, Inc. , In state court, Creazzo remains binding precedent. 3d 1245 (N.J. 2d at 1013-14. Similarly, in Forrest v.

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Compliance FDA Governance State Policy 52

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 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. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Albrecht , 139 S.

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