• Feature ArticlesFeature Articles

    Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners

    Ideally, the drug development pathway aligns with the companion diagnostics (CDx) validation on stages and steps in that the efficacy of the drug and CDx are clinically validated together as part of a phase 3 trial. However, the market is trending toward earlier submissions from the drug side. Specifically, if efficacy is shown in a phase 2 study, then a new drug application (NDA) or biologics license application (BLA) could be submitted using this information, especially...
  • Regulatory NewsRegulatory News

    Euro Convergence: Experts share advice, concerns and expectations for IVDR

    In a panel at RAPS’ Euro Convergence, top experts on the EU In Vitro Diagnostic Regulation (IVDR) discussed the state of the industry just 18 months before the regulation’s May 2022 date of application.   Opening the session, Gert Bos, executive director and partner at Qserve Group, laid out the stakes for IVD developers: “Yes, IVRD is different from [the Medical Device Regulation ] MDR, the pressure is much higher because there is such a big gap between the current...
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    Convergence: Global planning is key to successful development of companion diagnostics

    Planning and alignment are the keys to successfully steering companion diagnostics through regulatory processes across the globe, according to experts who spoke at RAPS Convergence 2020.   “The most critical way to develop a companion diagnostic is really a coordinated, co-development model, and this is the most effective path to regulatory approval,” said Ken Butz, associate director of regulatory technical advisors at PPD, and the leader of a session on the evolving ...
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    CDRH officials reflect on COVID diagnostics approach

    In a perspective published in the New England Journal of Medicine on Wednesday, top officials overseeing diagnostics at the US Food and Drug Administration (FDA) reflect on lessons learned during the agency’s response to the coronavirus disease (COVID-19) public health emergency.   On 4 February, just weeks after the first case of COVID-19 was detected in the US, FDA issued an emergency use authorization (EUA) for a test developed by the Centers for Disease Control...
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    FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic

    This article discusses the evolution and implementation of the emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for diagnostic devices during the COVID-19 pandemic in the United States. The author suggests that this limited oversight will affect future requirements for demonstrable superiority claims after the EUAs are terminated and diagnostics for the virus undergo increased scrutiny by the agency for marketing authorization. She covers the ...
  • Regulatory NewsRegulatory News

    Fourth notified body designated under IVDR

    Germany’s TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the fourth notified body designated under the In Vitro Diagnostic Regulation (IVDR).   TÜV SÜD, Germany’s second notified body under the IVDR, joins Germany’s DEKRA Certification GmbH and BSI’s UK and Netherlands arms, BSI Assurance UK Ltd and BSI Group The Netherlands B.V.   The newly designated notified body will be a welcome addition for industry, as the number of notified bodies des...
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    FDA Proposes Radiological Health Deregulatory Action

    The US Food and Drug Administration (FDA) on Friday proposed to amend and repeal parts of the current radiological health regulations regarding certain recommendations, including radiation protection during medical procedures and performance standards for diagnostic x-ray systems. The action sought via the new proposed rule also covers recommendations under the radiological health regulations on diagnostic x-ray systems’ major components, laser products, ultrasonic ther...
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    FDA Drafts Guidance on Oncology Companion Diagnostics

    The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling. “We’re concerned that the situation is not optimal for patient care because a clinician may need to order a different companion diagnostic, obtain an additional biopsy from a patient or both, to have additional therapy treatment options,” US Food and Drug Administration (FDA) Commissioner Scott G...
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    FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation

    After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May , the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes. At the outset of the investigation, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said the agency was working to determine the root ca...
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    New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs

    In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to submit a new 510(k) for certain changes to their tests. Under the policy laid out in the 2003 guidance , IVD makers can add either a cleared reagent to a previously cleared instrument or a new instrument "family member" to a previously instrument family without requiring a new 510(k). FDA...
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    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
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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...