• Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Emerging Manufacturing Tech Program

    The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing. "In recent years, we've seen significant advances in the modernization of drug manufacturing, including shifts to continuous manufacturing and the first 3D printed drug. These advancements have led to improved products for pa...
  • Regulatory NewsRegulatory News

    FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices

    The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA). Under the guidance, FDA will issue more prompt notifications to the public about medical device "emerging signals," including information that supports a new causal association or a new aspect of a known association between a device and an adverse event, or new information determined by FDA to h...
  • Regulatory NewsRegulatory News

    A Look Into the Future: FDA Wants to Know What’s Coming for Scientific Advances

    New advances in gene editing, precision medicine and synthetic biology are all likely to have a major impact on how the US Food and Drug Administration (FDA) shapes its regulations in the near- and long-term. Now, FDA is formally asking interested parties to offer some fresh perspectives on these and other emerging technologies and cross-cutting scientific advances that could be of importance to FDA, with a focus on areas that may impact FDA in five to 10 years. “FDA's ...
  • Regulatory NewsRegulatory News

    Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals?

    Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated. In January, FDA released draft guidance outlining how it plans to track and release early signals on medical device safety. The release of such information is expected to be for concerns that have yet to be fully analyzed, validated or confirmed by the agency and ...
  • Regulatory NewsRegulatory News

    FDA to Release ‘Emerging’ Safety Info on Devices

    As the US Food and Drug Administration (FDA) looks to catch signals of medical device safety issues earlier to prevent adverse events, the agency has put out draft guidance outlining how it will track and release such information publicly. The release of the new information -- for concerns that have yet to be fully analyzed, validated or confirmed by the agency -- will come in addition to the recall notices, safety communications and press releases that the agency alread...
  • Feature ArticlesFeature Articles

    Applying Ethics to Conflicting Healthcare Philosophies: The Ebola Example and the RAPS Ethics Code

    The Ebola crisis has brought more than anxiety to the US; it has brought controversy in the form of conflicting treatment recommendations for individuals returning from African countries affected by hemorrhagic fever disease. How does a regulatory professional determine how to respond in the face of conflicting philosophies on best practice for developing a treatment or prevention protocol? This article looks at the Regulatory Affairs Professionals Society (RAPS) Co...
  • Plastics Advancements Show Global Growth Potential

    • 27 August 2012
    A new research report shows certain regions are laying out the welcome mat for plastic processors, fueling growth in medical device manufacturing. The report from "Plastics News" highlights China, India, Brazil, and Costa Rica as areas where medical device makers can find favorable conditions for their business. "Medical Device Market Review and Outlook 2012" also calls the US Food and Drug Administration requirements "stringent" and "time-consuming and costly." "Plast...