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FDA Issues Revised Draft Guidance on "Off-Label" Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain | Dechert LLP

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance. ....

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Considering the Due Diligence Ramifications of Healthcare Enforcement in a Post-Pandemic World | Gardner Law

After a year-over-year reduction in drug, device, and biologic Warning Letters from 2012 through 2019, Warning Letters spiked to pre-2014 levels in 2020 during the pandemic. This was. ....

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