• Regulatory NewsRegulatory News

    Patient Experience Data: FDA Drafts Guidance

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday published new draft guidance to help stakeholders submit a proposed draft guidance on patient experience data. The 12-page draft guidance, which provides information in a Q&A format, addresses questions relating to both guidance development and other potential pathways for contributing patient experience data. “Today’s guidance document is part of our commitment to advance p...
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    Data Integrity Q&A: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in thei...
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    CDRH Works on Clinical Objectivity in Patient-Reported Outcomes

    A new study conducted by mathematical statisticians at the US Food and Drug Administration (FDA) bridges the gap between an objective endpoint and a patient-reported outcome (PRO). The research , led by statisticians Chul Ahn and Xin Fang at FDA’s Center for Devices and Radiological Health (CDRH), seeks to arrive at an acceptable level of probability for a PRO measure to reveal the “truth” of a subject’s disease or health condition. It comes at time when the science of ...
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    FDA Finalizes Guidance on PRO Assessment Tool for COPD Trials

    The US Food and Drug Administration (FDA) on Monday finalized guidance to help sponsors developing drugs to treat chronic obstructive pulmonary disease (COPD) to use the St. George’s Respiratory Questionnaire (SGRQ), a patient-reported outcome measure (PRO) assessment tool, in clinical trials. The 8-page guidance, which was revised in draft form in May 2016, notes that sponsors can can use the SGRQ as a PRO assessment of efficacy in submissions to investigational new ...
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    Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Provides Guidance as Black Triangle Adverse Event Scheme Goes Live Australia’s Therapeutic Goods Administration (TGA) has posted guidance on its black triangle adverse event reporting scheme. The scheme came into force at the start of the year, leading TGA to share a guide that addresses some of the uncertainties expressed by industry in advance of the go-live day...
  • Feature ArticlesFeature Articles

    Regulatory Challenges for Direct-to-Patient Clinical Trials

    p> On-site clinical trials may present a number of participation obstacles for individuals living at distances from clinical trial sites or for patients with mobility problems. Direct-to-patient clinical trials can be an alternative. This article reviews applicable regulations and analyzes current strategies for conducting direct-to-patient clinical trials using technologies, such as mobile 'apps' and wearables to report data, as well as the potential for sending trial dr...
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    How to Conduct Data Integrity Investigation Interviews

    Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...
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    CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017. Over a six-year period, the report says CDRH observed a more than 500% increase in the number of pre-market submissions that include PRO measures. And in FY 2017, more than 75% of approved, pivotal original and new study investigational device...
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    NEST Seeks Medical Device Test Cases for Using Real World Evidence

    The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices. Background In 2016, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) awarded a $3 million grant to the Medical Device Innovation Consortium (MDIC) to establish NESTcc. The cente...
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    FDA Seeks Input on Analysis Data Reviewer's Guide for Drug Submissions

    The US Food and Drug Administration (FDA) on Tuesday opened for public consultation a proposed analysis data reviewer's guide (ADRG) template developed as part of a collaboration with the Pharmaceutical Users Software Exchange (PhUSE). FDA says it is seeking comments from stakeholders to inform its review of the proposed template to determine whether the agency will recommend the template as is, or with modifications, for regulatory submissions involving study data. Acc...
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    FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling

    The US Food and Drug Administration (FDA) on Friday finalized two guidance documents, including one related to medical device manufacturers sharing information with patients upon request, and another to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. Sharing Patient Info The five-page guidance, first released as a draft in June 2016 , is meant to convey FDA's position on manufacturers ...
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    Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities

    Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices. Owen Faris, clinical trials director at the Center for Devices and Radiological Health (CDRH), said the opportunity to engage with patients goes beyond using patient reported outcomes (PROs) and patient preference information (PPI) in regulatory decision-making. A...