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  • Regulatory NewsRegulatory News

    FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

    The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017. FDA announced the changes in the Federal Register on Thursday, saying it "will no longer accept ISO 13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to assist transitioning manufacturers over to MDSAP." ISO 13485:2003 Submission Pilot In 2010, FDA released ...
  • Regulatory NewsRegulatory News

    Researchers Question FDA's Use of Surrogate Endpoints for Cancer Drug Approvals

    Two researchers are questioning the US Food and Drug Administration's (FDA) use of surrogate endpoints in approving new oncology drugs and the agency's failure to more strictly enforce postmarketing study requirements for these drugs, according to a letter appearing in JAMA Internal Medicine . Drugmakers have increasingly relied on surrogate endpoints to support the approval for new cancer drugs. Instead of demonstrating improvements in overall survival, often called "t...
  • Feature ArticlesFeature Articles

    Celebrity Endorsements—Lights, Camera, Enforcement Action?

    This article discusses the use of celebrity endorsements to promote a disease state or a pharmaceutical drug.  Celebrities grab attention everywhere they go. In fact, it is what they are paid to do when they endorse a pair of sneakers or an underwear brand. Just look at William Shatner, best known as Captain James Kirk from Star Trek, who has everyone humming “Price-Line-Negoti-ator!” Or hear Samuel L. Jackson asking, “What’s in your wallet?” each time someone t...
  • Regulatory NewsRegulatory News

    Kim Kardashian Selfie Prompts FDA Warning Letter

    FDA warning letters rarely make it into mainstream media, but this week one warning letter took the Internet by storm. If you're reading this site, you've most likely seen the headlines already. An Instagram post from reality television star Kim Kardashian, in which she raved about the morning sickness drug Diclegis, was the focus of a warning letter from FDA. Background The story first broke in mid-July, when Kardashian posted a photograph of herself to Instagram with...
  • RAPS' LatestRAPS' Latest

    Regulators, Industry Discuss Potential Impact of IMDRF

    The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions. The organization, launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), sports an impressive array of members for an organization in its infancy: the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's Nationa...