• In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

    In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug. Background: What's an RMP? The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known r...
  • FDA's Adverse Event and Postmarketing Surveillance Efforts get Major Data Boost

    The US Food and Drug Administration's (FDA) efforts to keep track of adverse events and medical outcomes is about to become even more robust thanks to the inclusion of the US' largest healthcare provider into its databases. That provider isn't a private insurer or company-it's the Department of Veterans Affairs' (VA) Veterans Health Administration ( VHA ), which serves nearly 9 million veterans each year at more than 1,700 facilities in the US. As part of VHA's mission,...
  • FDA Research Finds Women Under-Represented in Post-Approval Device Trials

    New research by regulators with the Center for Devices and Radiological Health (CDRH) has found that gender-specific data is not always assessed in postmarketing studies on the safety and efficacy of a device, potentially putting women at risk. Emphasis on Women CDRH, the US Food and Drug Administration's (FDA) medical device regulatory division, has been placing an increasing emphasis on the needs of women in recent years. In December 2011 it released a draft guidanc...
  • FDA Looks to Registries and New Adverse Event Reporting Systems to Improve Device Safety

    US medical device regulators may be getting a lot of attention of their new proposals to finalize a unique device identification (UDI) rule, but four other proposals will be critical as well in the US Food and Drug Administration's (FDA) attempts to build a national postmarket surveillance system, says a new agency report. Background Numerous issues associated with medical devices in recent years have highlighted the importance of developing new ways to keep track of me...
  • Researchers: FDA Needs to Take More Control over Postmarketing Studies

    The manner in which US regulators assess the safety of prescription drug products after approval is in serious need of reform, opines a trio of researchers writing in the New England Journal of Medicine (NEJM) . The authors, Michelle Mello, Steven Goodman and Ruth Faden-all of whom were associated with the Institute of Medicine's (IOM) May 2012 report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs -argue that scientific and ethical issues...
  • EMA Phasing Out Follow-Up Measures

    The European Medicines Agency (EMA) is phasing out so-called "follow-up measures" for human drugs requiring post-marketing studies this month, instead replacing them  with three categories of post-marketing commitments: Conditions in Annex II (obligations or specific obligations to fulfil post-authorization measures); Additional pharmacovigilance activities in the risk-management plan; Recommendations for further development. The old "follow-up measures" estab...
  • Post-FDAAA, Regulators Move to Adapt to Changing Risk Models

    With all the attention given to the US Food and Drug Administration's (FDA) approval process, it can sometimes be easy to forget an equal amount of its time is spent on postmarketing issues related, in part, to product safety. Two components of assuring a product's safety involve adverse event reporting (AER) and risk management plans, both of which were the focus of a presentation given at Harvard Medical School in early May 2012. In his presentation, Dr. Gerald Dal Pan...
  • EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

    The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified cells. The scientific guideline addresses the three main areas of drug development: quality considerations within the manufacturing process, non-clinical testing and clinical testing. EMA notes genetically modified cells may either be used as therapies themselves or as part of t...
  • IOM Issues Report on Studying Safety of Approved Drugs

    The Institute of Medicines (IOM) has released a consensus report on ways to improve the US Food and Drug Administraiton's (FDA) oversight of the safety of already-approved drug products. The report, entitled Ethical and Scientific Issues in Studying the Safety of Approved Drugs , explores a paradox often faced by FDA: only products that are safe should be approved, but the true safety profile of a product is difficult to ascertain until it has been used in real-world co...
  • EU Looks to Tighten Medical Device Safety With Implant Registry

    The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports Fierce Medical Devices . "These proposals include the creation of breast implant registers, product traceability and a pre-market authorization system--among other items--to prevent future such episodes involving implantable devices," wrote Fierce . A Committee withi...
  • Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis

    Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a meeting of healthcare journalists the agency is heavily invested in tracking postmarketing regulatory issues and has made significant advancements since 2008, reports Reuters . "Our oversight of the safety of marketed drugs has changed significantly over the past few years," said Woodcock in a statement. "This report shows that the quality, acco...
  • After Regulatory Issues Raised, Medtronic Plans to Heighten Postmarketing Safety Monitoring

    After a string of "headline-grabbing" recalls involving medical devices in recent months, Minneapolis-based medical device manufacturer Medtronic is announcing its intent to increase its postmarketing safety surveillance of its implantable products, reports Reuters . "The US Food and Drug Administration (FDA) alone does not have the infrastructure," said Medtronic CEO Omar Ishrak in an interview with Reuters , "so companies have to play a leading role in this." "We ne...