• Regulatory NewsRegulatory News

    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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    European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Tasks ex-GSK CEO With Highlighting Drugs Eligible for Accelerated Access Pathway The UK has tasked former GlaxoSmithKline CEO Sir Andrew Witty with highlighting products suitable for its incoming accelerated access pathway (AAP). Products that follow AAP will benefit from support with evidence generation and a more seamless journey to market, features the government ...
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    FDA Widens Expanded Access Navigator as Johnson Presses House to Pass Right-to-Try

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced that a web platform to help patients find information on clinical trials for cancer drugs would be expanded to include orphan disease drugs. The decision follows a House Energy & Commerce Committee hearing last month on a bill that passed the Senate in August and seeks to speed and increase access to experimental therapies for terminally ill patients. In written comments to...
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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...
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    FDA Holds First Patient Engagement Advisory Committee Meeting

    The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices. The meeting focused on a number of key issues related to clinical trials, with the goal of increasing patient input on trial design; patient recruitment, enrollment and retention; and communicating results back to patients. Patient Engagement at FDA FDA ...
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    FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing

    The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...
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    FDA: 30 Percent of Drugs Used in Expanded Access Programs are Later Approved

    A new paper by a team of US Food and Drug Administration (FDA) officials finds that only about 30%of drugs requested for expanded access go on to be approved by the agency. "Expanded access provides just that: access. There is no guarantee that the product sought will be effective and/or safe, much less that it will be effective and/or safe for the particular patient," the authors write. Background In recent years, the debate over patient access to unapproved drugs has...
  • Feature ArticlesFeature Articles

    Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes

    This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement. Introduction Wearable technologies and mobile Health (mHealth) devices are increasingly helping patients report meaningful outcomes and manage their conditions while enhancing their quality of life. Wearable technologies are "smart" electronic devices...
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    FDA Explains Emergency Expanded Access Application Process

    The US Food and Drug Administration (FDA) has laid out the process by which doctors can access an investigational drug for treatment in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures. The release of the MAPP coincides with a bill passed in the Senate and making its way through the House that aims to ease the process by which terminal patients can access such investigational dr...
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    GAO: FDA Improved Expanded Access but More Clarity Necessary

    With the rise of Right-to-Try legislation across states in the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA). But a new Government Accountability Office report released Tuesday lends credence to many who have voiced concerns with the Right-to-Try laws,...
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    Industry Supports FDA Proposal to Create New Office of Patient Affairs

    Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs. The idea for the new Office of Patient Affairs (OPA), proposed in March , is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquir...
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    UK Patients to Get Early Access to AbbVie's HCV Combo

    Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday. The combination, known as glecaprevir/pibrentasvir, is currently undergoing an expedited review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its potential to treat patients across all six major genotypes of HCV, with or wi...