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Warning Letters › Regulatory Requirements › Marketing

Arnall Golden Gregory LLP

Not a Second Time: FDA’s Office of Prescription Drug Promotion Issues a Warning Letter to a Company for Unlawful Promotion

Arnall Golden Gregory LLP on

The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more

Arnall Golden Gregory LLP

OPDP is Still Standing: FDA’s Office of Prescription Drug Promotion Issues Two Enforcement Actions Since Recent Layoffs

Arnall Golden Gregory LLP on

Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more

Womble Bond Dickinson

Insight into Medical Foods and the Scope of FDA Regulation

Womble Bond Dickinson on

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more

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