After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which...more
Makers, distributors, program planners and administering entities of coronavirus (COVID-19) countermeasures are protected from liability under a declaration issued by the Department of Health and Human Services (HHS)...more
3/17/2020
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