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  • Regulatory NewsRegulatory News

    New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes

    US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program. Background The openFDA initiative was born from a May 2013 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public. At th...
  • Brazilian Regulators Propose Switching From Paper to Electronic Permit Submissions

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has opened a consultation (20/2013) regarding its proposal to switch from paper-only to e-format-only submissions for Operating Permits (AFE) and Special Authorizations (EA), documents that are necessary for any company that has Anvisa-regulated products such as medicines. The proposal also would: establish automatic renewal of AFEs and EAs harmonize the technical requirements that must be met by companies...
  • CBER Wants Better Vaccine Safety, Identify Adverse Events

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is announcing its intent to launch a program to ensure the safety of vaccine products manufactured around the globe by enhancing the regulatory capacity of emerging nations. CBER's initiative, dubbed the "Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) initiative," is in response to what FDA described as a "dramatic increase in the global use of vacci...
  • FDA, ISMP Announce New Initiative to Reduce Medication Errors

    The US Food and Drug Administration (FDA) announced Monday (2 April) it has formalized an existing relationship with the Institute for Safe Medication Practice (ISMP) to help protect consumers from medication errors. ISMP, a Pennsylvania-based non-profit, is focused on ways to prevent medication errors through making changes to labeling, packaging, prescribing, dispensing and other communications in the dispensing process. ISMP already operates a national Medication Err...
  • Study: Medical Device Safety Could Be Improved With Help of Software

    • 09 March 2012
    A new study published in the American Health Association's journal Circulation: Cardiovascular Quality and Outcomes says that commercially available software could discover problems with medical devices well before traditional adverse event tracking systems are able to, reports Fierce Health IT . The study looked at 2710 implantable cardioverter-defribrillator leads, of which 107 failed during the study. Software used by the study was able to successfully alert the au...
  • 86% of Adverse Patient Events Go Unreported in Hospitals

    • 09 January 2012
    The US Department of Health and Human Services' (DHHS) Officer of the Inspector General (OIG) released a report on Friday, 6 January indicating that six in seven adverse events (AEs) that take place in hospitals go unreported. The OIG's Director, Daniel Levinson, noted that all hospitals being paid under Medicare are obligated to "track medical errors and adverse patient events, analyze their causes" and make improvements to reduce future incidence of AEs. Levinson fur...