2014 and FDA Compliance - Drug Discovery Digest

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2014

FDA Compliance

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

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. A plaintiff’s pursuit of such theories thus should allow admission of standards compliance evidence. Coffing Hoist Division , 528 A.2d

Compliance

Compliance Government FDA Compliance Production

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. The court also disagreed with defendants’ argument that plaintiff’s claims should be time barred because she alleges that she began experiencing symptoms soon after her surgery in 2014 and therefore, she should have discovered her injury before the statute of limitations ran in 2017.

FDA

FDA FDA Compliance FDA Approval Trials

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

A Thorny PMA Preemption Decision from Rhode Island

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