2014, FDA Compliance, Regulations and Trials

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2014

FDA Compliance

Regulations

Trials

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. and [defendants’] response thereto, the trial court did not abuse its discretion by disallowing the 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. We do not believe that the trial justice abused her discretion in so ruling. The trial justice was entitled to conclude that the various patients mentioned in these reports were not necessarily similarly situated to each other or to [the decedent]. at *1-2.

FDA

FDA FDA Compliance FDA Approval Production

Drug Discovery Digest

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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