News & Analysis as of

Warning Letters Notice of Violation

Arnall Golden Gregory LLP

It Cuts You Up: OPDP Issues an NOV to a Dermatologic Drug Company

Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation....more

Gardner Law

Responding to Letters from FDA

Gardner Law on

There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in the form of a Warning Letter, an Untitled Letter, or an “It Has Come to Our Attention” Letter. Any...more

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