2014, FDA Compliance and Trials - Drug Discovery Digest

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2014

FDA Compliance

Trials

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

Drug & Device Law

JANUARY 15, 2024

A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion.

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

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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