• Regulatory NewsRegulatory News

    Reassessing Benefit-Risk: FDA Preps for New Guidance

    US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at FDA’s Center for Drug Evaluation and ...
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    Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations

    The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors. Background In 2009, FDA began work to develop a structured approach to conducting benefit-risk assessments as part of an effort to bring more clarity and consistency t...
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    FDA Updates on Two ICH Guidelines

    The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents. For the first update, FDA issued a draft guidance for public comment in line with ICH's revised guideline on the efficacy portion of the CTD, M4E(R2) – Efficacy , w...
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    Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees

    Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy. “Some argue that individuals and their physicians should be free to make these decisions without relying on FDA to make determinations about marketing approval. However, the complexity of the data as well as examples ...
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    AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices

    Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions. The draft guidance, released in July and known as “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions,” is meant to bring FDA’s be...
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    FDA Finalizes Two Medical Device Guidelines

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform FDA's benefit-risk determinations. The 62-page guidance on benefit-risk determinations, finalized more th...
  • Feature ArticlesFeature Articles

    Advancing Regulatory Science: Research Success in a Public-Private Partnership

    This article discusses how a public-private partnership brought stakeholders together to advance regulatory science research in patient preference assessment. In May 2015, the Medical Device Innovation Consortium (MDIC) published a first-of-its-kind report, "A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology." 1 This "Framework" is not only a break-through publication in the...
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    BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA

    Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues. Background The call comes in the midst of a sustained shift by both companies and regulators to incorporate the views of patients into the regulatory process. Starting in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA has begu...
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    How do you Weigh Benefits and Risks in Medical Device Trials? FDA Guidance Explains

    Which factors should medical device manufacturers take into account when trying to determine whether an investigational device is suitable to begin testing in humans? The US Food and Drug Administration (FDA) has some thoughts on the matter, contained within a new draft guidance document released on 17 June 2015. Background The guidance, Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs) , relates t...
  • 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...
  • 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...