• EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward

    EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication errors. That workshop , held in February 2013, brought together regulators across the EU in the hopes of raising awareness around new legal requirements for reporting medication errors and to generate best practices for EU regional regulators. Those errors, as defined by the a...
  • Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles

    • 16 May 2013
    Recall reporting and consulting firm Stericycle is out with its latest quarterly report regarding the state of industry recalls, showing a disturbing trend in recalls led by compounding pharmacies and large-scale medical device problems. Pharmaceuticals Pharmaceuticals as a category is made up of two types of products: Drugs manufactured under traditional conditions, such as in a large-scale manufacturing facility, and drugs that are compounded, often on a one-off bas...
  • Are Medical Countermeasures Meeting the Potential Needs of Children?

    Is the US government doing enough to protect children from the threat of a medical emergency caused by a chemical, biological, radiological or nuclear accident? Not as much as it could be, concludes a new report just published by the Government Accountability Office (GAO), an intra-government watchdog that regularly assesses programs for deficiencies. Background Since the events of September 2011, federal agencies, and particularly the US Food and Drug Administration (F...
  • New Data Show Clinical Trials Conducted Outside of US, EU Have Nearly Doubled since 2005

    A new "comprehensive analysis" conducted by the European Medicines Agency (EMA) has found that more than 60% of patients enrolled in pivotal trials submitted in support of drug applications-that is, Phase III clinical trials meant to assess a drug's efficacy and safety in a large patient population-were recruited from outside of the European Economic Area (EEA), calling attention to the difficulties regulators face in policing global clinical trials. Background The repo...
  • Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data

    A new report published by the US government Accountability Office (GAO), a intra-government watchdog that assesses programmatic weaknesses, has informed the US Food and Drug Administration (FDA) that it could be doing a better job at utilizing the information it collects on adverse events for dietary supplement products. Background The 18 March 2013 report reflects a complicated regulatory area for the agency, in which products-some of which contain pharmaceutical or ph...
  • MDUFA Goals Met in 74-85% of Cases in 2012, FDA Report Says

    The US Food and Drug Administration (FDA) has released a new congressional report it wrote regarding its performance under the final fiscal year of the Medical Device User Fee Act (MDUFA) , a law intended to help the agency access more funding in return for meeting more stringent timelines for the review of medical devices. The second iteration of the act, MDUFA II , was passed in 2007 under the Food and Drug Administration Amendments Act (FDAAA) , and contains numero...
  • China FDA Report Claims Reduced Drug Lag

    A new report released by China's State Food and Drug Administration's (FDA) Center for Drug Evaluation shows that review and approval times for clinical trial applications for most drugs averages about 8 months per products, while oncology products fare the best at five months. The report , released 28 February 2013, also noted that "the gap between the time-to-market of imported drugs at home and abroad also significantly shortened" relative to years prior. The SFDA e...
  • CDRH Report Shows Steady Increase in Complaints, but Few Clear Reasons Why

    The Center for Devices and Radiological Health's (CDRH) ombudsman has released a report indicating that complaints made against the center and its employees have increased for a fourth straight year. The data-driven annual report is an accounting of the total number of inquiries, complaints, disputes and other points of contact made to the ombudsman's office during each calendar year. The report is meant to identify any lingering issues that might be affecting the agency...
  • Survey Shows Regulatory Concerns Rank Highest in Device Industry

    Members of the medical device community are concerned about the enormous difficulties of keeping up with regulatory burdens and an increasingly difficult set of regulatory agencies to deal with, reports a new survey . Survey Highlights Views of Regulatory, Quality Professionals The survey, of 3,509 industry professionals, was conducted by the Emergo Group, a global regulatory consultancy. While perhaps not the most scientific of all studies-the sample was obtained thr...
  • Report: Average 510(k) Review Time of 138 Days Remains Close to Record Highs

    • 19 February 2013
    A recent report published by consulting company Emergo Group shows that review times for 510(k) submissions improved slightly in 2011, but remains close to the record highs seen in 2010 that have upset many in industry. Emergo's report, An Analysis of US FDA 510(k) submissions received between 2006 and 2011 , tracks statistics associated with 510(k) premarket notification submissions. Under FDA regulations, companies intending to market a device that is substantiall...
  • Government Report Shows Endemic Deficiencies in REMS Assessments

    A new report just published by the Department of Health and Human Services (DHHS) claims that the US Food and Drug Administration (FDA) lacks sufficient data to determine whether one of its flagship postmarketing safety methods, Risk Evaluation and Mitigation Strategies (REMS), is actually effective at ensuring product safety. Background REMS plans were instituted in 2007 under the FDA Amendments Act , and were seen as a response to a number of product safety scandal...
  • 'Record-Breaking Year' for Fraud Recovery Has Roots in Regulatory Missteps

    2012 was a record year for regulatory-related pain and government gain, claims a new report out from the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office responsible for overseeing fraud prevention and recovery efforts. The report , jointly authored by OIG and the US Department of Justice (DOJ), explained that 2012 saw the highest-ever amount of fines recovered from those who had defrauded or attempted to defraud the g...