• FDA Looks to Recalibrate how it Uses Non-Traditional Data to Support Regulatory Decisions

    The government may be partially shut down and the Federal Register all but empty, but that doesn't mean the US Food and Drug Administration (FDA) isn't still announcing upcoming meetings. On 4 October 2013, the agency announced it will soon hold a public meeting on "meta-randomized controlled clinical trials for the evaluation of risk to support regulatory decisions." Background The meeting, it explained, will present various scientific approaches on how to conduct a...
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    A (Technologically Stunted) Ad/Promo Reviewer Looks at Techy Solutions to Regulatory Issues

    I thought I was technologically savvy; at any given moment, I was juggling an iPhone, laptop, Blackberry, Kindle, iPad and who knows what other piece of technology I didn't actually need. Then, to my surprise, I encountered other "popular" forms of technology of which I was completely unaware. For instance, when interviewing potential candidates at a recent conference, I was handed business cards printed on the back with little boxes containing Rorschach-like images. Afte...
  • FDA Seeks to Determine how Consumers Find Health Information Online, Perceive Benefit-Risk

    Direct-to-consumer marketing is a topic of regular interest to regulators with the US Food and Drug Administration. At various times during the past several years, it has announced studies involving the use of composite scores in DTC advertising, the affect of DTC advertising on healthcare professionals , and corrective advertising resulting from improper DTC marketing. Now it's making some substantial changes to a DTC study first approved in 2011, according to docu...
  • UK’s MHRA Proposes Tracking System for High Risk Devices

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four National Health Service hospitals have agreed to pilot a new tracking system for high risk medical devices.  The goal of the tracking system, one of 11 projects established by the agency in response to the Poly Implant Prothèse silicone breast implant issue, is to improve the monitoring of medical devices such as breast implants, heart valves and pacemakers. The new...
  • FDA Announces Meeting Intended to Start Standardization Process for REMS

    US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a series of tools required of some drugs by the US Food and Drug Administration (FDA) to control the potential risks associated with use of a drug product. Background REMS were first introduced under the 2007 FDA Amendments Act (FDAAA) , and were meant to act as a regula...
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    Assessing Benefits Versus Risks in Europe--the New Focus in Pharmacovigilance

    Benefit:risk (B:R) assessment is a critical step in the process of approving a drug and in re-assessing an already marketed drug, in the case of newly identified important safety signals. B:R assessment is a holistic process that requires data from different sources to be reviewed to reach a decision on whether a drug's benefits outweigh its risks. 1 Due to the heterogeneity of the data under review (e.g., toxicological, efficacy and safety), all previous approaches usin...
  • FDA Publishes New Benefit-Risk Paradigm Framework, Rejects Quantitative-Only Approach

    The US Food and Drug Administration (FDA) has published a new report calling for a new drug regulatory decision-making paradigm for risk-benefit assessments, rejecting calls for a quantitative-only approach to regulation as counterproductive to its goals to make the decision-making process as clear and predictable as possible. Background The plan, published on 5 March 2013, notes that FDA's mission calls for it to approve drugs that are both safe and effective. But the ...
  • 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...
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    Book Excerpt: Risk Management in the Future: Looking Into the Crystal Ball

    Chapter 15 Pharmacovigilance has been defined by the World Health Organization as, "The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem." 1 Pharmacovigilance (or risk management) should help to inform both healthcare professionals and patients, allowing them to make educated decisions when choosing a treatment. 2 The main methods for pharmacovigilance are randomized trials,...
  • High Risk Devices to be Excluded From EU Mutual Recognition Agreement

    High-risk medical devices will no longer be eligible for mutual recognition of conformity assessment with the European Union (EU) as of 1 January 2013, according to the amended Mutual Recognition Agreement (MRA) concluded between Australia and the EU. All Class III-high risk-medical devices are excluded from the MRA until the appropriate confidence building activities have been undertaken between the two parties. Also excluded from the amended MRA are certain medical ...
  • 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...