• Overestimated Efficacy, Underestimated Risks Guide Patient Treatment Options

    • 13 November 2012
    Patients and physicians alike often have lofty expectations and aspirations about the effectiveness of a prospective treatment. But, as a new article in the Annals of Family Medicine argues, those expectations contribute significantly to both the increasing costs of healthcare and avoidable harms suffered by patients. At the core of the healthcare cost crisis right now is an unavoidable fact, writes Steven Woolf, MD: The cost of obtaining healthcare, and in particular ...
  • FDA Plans to Review REMS, ETASU Strategies for Teratogenic Products

    The US Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee (DSaRM) is preparing to meet in December to discuss risk management strategies for teratogenic products. Teratogens are most commonly pharmaceutical products which, when taken by a pregnant woman, can cause birth defects or other developmental abnormalities. One of the most notorious teratogens is Thalidomide, a drug used briefly in the 1950s and 60s to treat the effects of mor...
  • EMA Launches EU-Wide Investigation into Roche for Alleged Pharmacovigilance Deficiencies

    The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes. The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company ...
  • EC Committees: Changes Coming to European Human Risk Assessment

    • 22 October 2012
    A new discussion paper generated by three of the EU's top scientific committee has called for a paradigm shift in the way regulators assess risks to human health from a hazard-driven process to one driven by exposure. The paper, Addressing the New Challenges for Risk Assessment , was issued by three of the European Commission's Scientific Committees: the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), the Scientific Committee on Consumer ...
  • FDA Advisory Committee to Assess 'Warning Fatigue'

    An advisory committee meeting convened on behalf of the US Food and Drug Administration (FDA) is set to discuss factors influencing the communication concerning regulated healthcare products, including pharmaceuticals, medical devices and biologics, FDA announced in the Federal Register . FDA's Risk Communication Advisory Committee (RCAC) is set to meet on 2 November 2012 to discuss the topic of message fatigue, warning fatigue and "inaccurate risk perception," all ...
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    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • FDA Plans to Evaluate Risk-Benefit Paradigms for 20 Disease Areas

    The US Food and Drug Administration (FDA) is planning a meeting to discuss the agency's patent-focused drug development initiative, an attempt to identify neglected or under-served diseases with an eye on generating a more nuanced understanding of patients' tolerance for risk. The initiative was included in the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) , contained within the FDA Safety and Innovation Act (FDASIA) . Section X of PDUFA instru...
  • Health Canada Releases New GMP Inspection Guidance

    New guidance released on 11 September by Health Canada makes changes to the way the agency classifies observations made during the course of a good manufacturing practice (GMP) inspection. The new system is intended to ensure uniformity between various regulatory agencies in Canada, the guidance explains. Inspection findings are at a high level segregated into one of two categories: compliant or noncompliant with the Food and Drugs Act . As is the case in other coun...
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    How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006 (Part 2)

    This two-part series provides insights into the new paradigm of biosimilar medicines based on approval and medical experience postapproval. It proposes a framework for the understanding, development and acceptance of a new generation of biologic medicines, biosimilars, in the US and worldwide. 1-3 Currently, the knowledge gathered by regulators and industry permits a degree of confidence in biosimilars authorized in the EU after nearly six years of pharmacovigilance, pr...
  • FDA Enacts New Class-wide REMS Policies for Opioids

    The US Food and Drug Administration (FDA) announced 9 July the approval of a new Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products. The new REMS policy will cover all extended-release (ER) and long-acting (LA) opioid products, and will rely primarily on educational products, which the m...
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    Innovation Leads to Transformation in Regulatory Agencies' Evaluation of Benefit-Risk

    Several innovations are currently being discussed or implemented by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). One key innovation area is the assessment of a medicinal products benefit-risk. A major focus is assessment of whether drug, device and biologic products have an appropriate benefit-risk balance for marketing approval and continued marketing. Recent International Conference on Harmonisation (ICH) guidelines, European legi...
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    Risk Management for Medical Devices - A Practical Approach

    Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission, which, by the way, is urgent. You have a look at the Design History File (DHF). There is an FMEA you hope is up-to-date; a risk management plan that unfortunately lacks typical deliverables and a method for systematically tying together risks, hazards, requirements, controls, verification and validation ...