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    Managing the challenges of the new IVDR: Lessons from the pandemic

    This article details how regulatory intelligence can help medtech companies assess the impact of the new EU legislative framework for in vitro diagnostics (IVDs). Using the example of COVID-19 antigen tests, the author looks at how regulatory intelligence helped device manufacturers manage the changes in regulations during the pandemic and how the lessons learned can support the industry in assessing and planning for the impact of the new legislative framework for IVDs tha...
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    FDA sends first warning letters for fraudulent marketing of antibody tests

    The US Food and Drug Administration this week issued its first set of warning letters for marketing adulterated or misbranded COVID-19 antibody tests.   The letters, sent to Medakit Ltd. of Hong Kong,  Antibodiescheck.com of United Arab Emirates, and Sonrisa Family Dental dba www.mycovidtest19.com of Chicago, cited a range of violations. These included offering test kits for sale in the US directly to consumers for at-home use without marketing approval, cleara...
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    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...
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    FDA Leadership Calls for LDT Reforms

    While championing advances made in diagnostic technology in recent years, top officials from the US Food and Drug Administration (FDA) are calling for a new regulatory framework for in vitro clinical tests (IVCTs) and laboratory developed tests (LDTs). The call comes as lawmakers from both parties on Thursday released a new 200-page discussion draft of a bill that would establish such a framework, incorporating many of the reforms FDA has recommended, including a pr...
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    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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    FDA Offers Two New Draft Guidances on Developing Targeted Therapies

    The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases, and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study. "New drugs are being developed based solely on their ability to target these und...
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    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
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    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
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    FDA Warns Lead-Testing Diagnostics Company

    The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations. The warning letter, which follows an inspection of the North Billerica, MA, site last May and June, notes that Magellan made a "significant change by adding to the device labeling an ins...
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    DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List

    A study on direct-to-consumer (DTC) drug advertising published Monday in Nature Human Behavior finds that consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed. "When commercials list severe side effects along with those that are most frequent…it dilutes consumers' judgements of the overall severity of the side effects," write authors Niro Sivanathan, associate professor of org...
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    FDA Launches New Online Portal for Requesting Pre-ANDA Meetings

    Thanks to the new Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) this week launched a new online platform to allow industry to request pre-ANDA (abbreviated new drug application) meetings for complex generic drugs.  The CDER Direct NextGen Collaboration Portal allows potential ANDA applicants to initiate requests by uploading a meeting request package and to submit supporting documents, such as meeting presentation materials, re...
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    FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

    A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks. According to the study, limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also impro...