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Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation

Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more

New Regulatory Pathway for Cannabidiol Products May be Forthcoming

The Food and Drug Administration (FDA) released a statement yesterday explaining its conclusion that a new regulatory pathway is needed to allow for greater oversight and to better manage risks associated with cannabidiol...more

FDA Issues Safety Communication About Genetic Non-Invasive Prenatal Screening Tests

Last week, the Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as “NIPS” or...more

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

The Not So Weaved Web: The Fate of CBD Products is in FDA’s Hands

More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more

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