• Regulatory NewsRegulatory News

    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...
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    Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance

    The US Food and Drug Administration (FDA) has made it a priority to find a balance between encouraging innovative medical products and increasing access to lower-cost pharmaceuticals under the Hatch-Waxman Act 1984 . But when it comes to finding ways to speed the influx of generic drugs and stop frequently cited abuses, a host of voices from industry, academia and Congress are offering differing views. In July, FDA held a meeting to discuss certain situations in ...
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    FDA Analyst Counters Critiques of Orphan Drug Act

    While recent reports have claimed that drugmakers are manipulating the incentives provided by the Orphan Drug Act , Mike Lanthier, an operations research analyst at the US Food and Drug Administration (FDA), says that in most cases, the act is working as intended. "My sense is that the Orphan Drug Act has been a successful catalyst for spurring rare disease development," Lanthier said at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC on ...
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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 ...
  • 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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    CDRH Clarifies Process for Consensus Standard Recognition Requests

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act . Medical device makers often rely on consensus standards in the development and testing of their products, and FDA allows device makers to submit a declaration of conformity to show that the...
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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...
  • Feature ArticlesFeature Articles

    Navigating the Medical Device User Fee Act (MDUFA)

    This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations. 1 Introduction The category "medical devices" encompasses a wide variety of products intended for diagnosing diseases or other conditions as well as the cure, mitigation, treatment or prevention of disease. 2 Among its responsibilities, the US Food and D...
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    Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation

    Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult. "We urge you to listen to both sides of the aisle and drop any attempts to implement the damaging proposed cuts at HHS laid out in your budget," they wrote. Trump’s budget blueprint for 2018 ...
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    BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices

    Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification. The comments follow the release in March of FDA’s draft list , which was released as part of a provision in the 21st Century Cures Act . The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like ...
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    EMA to Continue to Allow Patient Involvement in CHMP Meetings

    The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before its Committee for Medicinal Products for Human Use (CHMP). In addition to continuing to invite patients to oral explanations on a case-by-case basis, EMA will also look to use additional methods and consult patients on a more regular basis. "This could include participating in CHMP discuss...