• 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...
  • 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...
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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 ...
  • 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...
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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...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...
  • New ICH Guideline on Periodic Safety Update Reports

    A new draft guideline put forth by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aims to "be a common standard for periodic benefit-risk evaluation reporting" for products marketed in ICH regions. The draft guidance, entitled E2C(R2): Periodic Benefit-Risk Evaluation Report ,  aims to "ensure that the periodic safety update reports for marketed drugs have the role of being periodic be...