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

Hall Render

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents.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.

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Poor Transparency and Corruption in Disease Reporting Could Precipitate the Next Pandemic

Bill of Health

In 1918, newspapers in France, England, and the United States were barred from reporting on the Spanish flu , contributing to its spread. Delayed reporting from Guinea, and then Liberia and Sierra Leone, enabled the spread of Ebola across West Africa in 2014.

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

Drug & Device Law

2004) (pre- Tincher product liability case; “assessment of the dangers of unfair prejudice and confusion of the issues are procedural matters that govern in a federal court notwithstanding a state policy to the contrary”); Kelly v. Coffing Hoist Division , 528 A.2d 2d 590 (Pa. Omega Flex, Inc. , 3d 328 (Pa. Blaw-Knox , 360 F.3d