Food and Drug Administration

Opinion Issued in Stem Cell Clinic FDCA Suit

An opinion was filed on Tuesday by the Central District of California in a...

Eleventh Circuit Sets Aside FDA Marketing Denial Letters...

On Tuesday, the Eleventh Circuit Court of Appeals issued an opinion setting aside marketing...

Oxford Pharma Seeks Declaratory Judgment Against FDA, Ala....

Oxford Pharmaceuticals LLC filed a complaint against Alabama State Board of Pharmacy, its...

Second Circuit Affirms Summary Judgment Ruling in Favor...

An opinion was issued on Friday in the Second Circuit by Circuit Judges Chin,...

Melinta Sues the FDA and HHS for Approving...

On Monday, Melinta Therapeutics, LLC and Rempex Pharmaceuticals, Inc. filed a complaint in the...

Avadel Sues HHS, FDA Over Delay in Approval...

Avadel Pharmaceuticals LLC filed a complaint against the Department of Human Health Services (HHS)...

Sprout Foods Partially Survives Labeling Challenge

An order was issued by Judge Richard Seebord on Monday partially granting a motion...

Juul Continues Pushback on FDA Marketing Denial

On June 24, following the Food and Drug Administration’s (FDA) marking denial order...