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  • Feature ArticlesFeature Articles

    Why Respond to an FDA 483 in a Timely Manner

    We reviewed some warning letters issued by the US Food and Drug Administration (FDA) this year that reminded us of the 1981 hit song by Styx, "Too Much Time on My Hands." Two companies had received a FDA 483 List of Observations following an inspection. 1, 2 The companies accordingly responded to the agency within 15 business days; however, they also provided subsequent substantive responses to the FDA 483 outside of the 15-day window. In the warning letters, FDA acknowl...
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    FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective

    Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. Recently, FDA issued Notice of Violation letters to drug companies for promoting their investigational new drugs as safe and effective. Introduction The US Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) did not take the summer off, despite the uncertainty sur...
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    Do Recent First Amendment Court Developments Deal a Blow to the Government?

    This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications. Introduction The US Food and Drug Administration has suffered two widely-publicized setbacks relating to off-label promotion oversight. In both cases—one involving a pharmaceutical company (Amarin) and the other a medical device firm (Vascular Solutions) and its chief executive officer—the governmen...