News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Due Process

Parker Poe Adams & Bernstein LLP

Public and Private Employees File First Challenges to Mandatory Vaccination Policies

In a pair of notable new lawsuits, employees of both public and private employers have filed legal challenges to mandatory COVID-19 vaccination policies. First, on April 16, 2021, in the Middle District of North Carolina, a...more

King & Spalding

District of Oregon Rejects Constitutional Challenge to Near-Billion-Dollar Damages Award for TCPA Violations

King & Spalding on

On August 14, the U.S. District Court for the District of Oregon issued an order rejecting defendant ViSalus, Inc.’s (“ViSalus”) constitutional challenge to a $925,220,000 verdict based on 1,850,436 prerecorded calls ViSalus...more

Clark Hill PLC

DELAYED: The FDA’s Intended Use Rule

Clark Hill PLC on

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

Arnall Golden Gregory LLP

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

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