2014, Compliance and State Policy - Health Care Compliance Brief

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2014

Compliance

State Policy

FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

Hall Render

JANUARY 30, 2025

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. That said, the Final Guidance is not for current implementation, pending the Office of Management and Budgets decision on the collection of information.

FDA

FDA State Policy Public Health Compliance

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

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

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FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

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

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