2014, FDA and State Policy - Health Care Compliance Brief

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2014

FDA

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This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.

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

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. In state court, Creazzo remains binding precedent. Coffing Hoist Division , 528 A.2d 2d 590 (Pa. Omega Flex, Inc. , 3d 328 (Pa.

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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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