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FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

FDA Law

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). Finally, the policy emphasizes the importance of validation data, and states that FDA is providing EUA templates. academic medical center laboratories).

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FDA Safety Communications: A Potential Provider Pitfall

FDA Law

The New Jersey Punitive Damages Act (PDA) provides that “punitive damages may be awarded. The specific actions a provider takes with regard to a safety communication could still provide evidence of actual malice or wanton and willful disregard, even though that standard was not met in this particular case.

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Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Common Sense Family Doctor

On the surface, this rule aligns with the American Academy of Family Physicians’ policy that information provided in DTCA "should be accurate, balanced, objective, and complete, not false or misleading, and should not promote unhealthy or unsafe practices."