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  • 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...
  • Company's Facebook Page Gets it in Trouble with FDA

    The US Food and Drug Administration (FDA) has issued a new Untitled Letter to a pharmaceutical company for allegedly misbranding its hypothyroidism drug on Facebook. Untitled Letters are essentially unofficial warnings from FDA that a practice-Untitled Letters are most often reserved for alleged marketing violations-runs afoul of federal advertising regulations. Unlike a Warning Letter, Untitled Letters do not threaten subsequent enforcement action by FDA. In its latest...
  • FDA Expresses Interest in Increasing Impact, Reach of Safety Warnings

    The US Food and Drug Administration (FDA) has announced that it will soon convene an advisory committee to discuss whether changes are needed to its " Consumer Updates " in order to make them more impactful and useful to consumers. Background At present, consumer updates are used by the agency to address important or pressing topics of public health interest. In recent weeks, FDA has issued Consumer Updates for topics including misbranded dietary supplements, the limita...
  • Upcoming FDA/IOM Meeting to Focus on Uncertainty During Regulatory Approvals

    An upcoming meeting between the Institute of Medicine (IOM) and the US Food and Drug Administration (FDA) will explore two facets of the benefit-risk assessment process that officials say could benefit from increased attention. Background Under Section 905 of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA is charged with implementing a "structured risk-benefit assessment framework in the new drug approval process to facilitate the bala...
  • 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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...