2014, FDA Compliance, Marketing and Regulations

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2014

FDA Compliance

Marketing

Regulations

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

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

It involves allegations against the manufacturer and distributor of surgical clips used in tubal ligation surgery—Class III Pre-Market Approved (“PMA”) medical devices. Plaintiff had surgery in 2014 in which the clips were used. 14, 2024). Shortly thereafter she began experiencing several adverse symptoms, including pain.

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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