2014, FDA Compliance and Regulations

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2014

FDA Compliance

Regulations

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 Trials FDA Approval

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

Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. 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

Drug Discovery Digest

A Thorny PMA Preemption Decision from Rhode Island

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

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