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  • Regulatory NewsRegulatory News

    FDA Draft Guidance on Broader Labeling for Oncology Companion Diagnostics Draws Mixed Reactions

    Developers of companion diagnostic (CDx) tests as well as pharmaceutical and biotechnology groups and companies expressed mixed reactions to the US Food and Drug Administration (FDA) draft guidance on broader labeling of in vitro CDx assays for a specific group or class of oncology therapeutic products. The support and concerns were expressed through comments recently submitted to FDA’s draft guidance document, which was released  last December. Some commenters showe...
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    CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request nonbinding feedback on actions such establishments propose to take to address an FDA Form 483. The draft standardized method has five parts. These relate to submitting a timely request—as defined by the agency—the statutory eligibility criteria, the device establishment’s ...
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    FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder

    The US Food and Drug Administration (FDA) issued draft guidance on Wednesday to aid sponsors in the clinical development of drugs and biologics for the treatment of eosinophilic esophagitis (EoE). The 13-page draft guidance document describes the agency’s clinical trial recommendations for EoE drugs. These relate to trial population and design, safety and efficacy considerations, clinical outcomes assessments, as well as pediatric considerations. The clinical developmen...
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    FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices

    Under a US Food and Drug Administration (FDA) contract, a new rubric developed by the Mitre Corporation is the first-of-its-kind to be specifically tailored to medical devices, and is set to take the form of a medical device development tool (MDDT) to ensure consistency in scoring cybersecurity risks. The common vulnerability scoring system (CVSS) open standard for assessing software vulnerability severity has seen widespread use on an international scale since its 2005...
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    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
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    Health Canada Seeks to Better Define Regulatory Requirements for SaMD

    Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD). Health Canada notified industry last year of its intent to release draft guidance on SaMD as part of a larger initiative to improve regulatory reviews. The timeline, however, was delayed after a Health Canada scientific advisory panel raised concerns over the previous approach, whic...
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    EMA Consults on Harmonized Antibacterial Drug Development Guideline

    The European Medicines Agency (EMA) on Monday released a draft version of its guideline on developing antibacterial medicines for consultation.   The 30-page guideline, which is now on its third revision, has been updated to reflect a harmonized approach to antibacterial drug development based on the tripartite discussions between EMA, the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency.   "Antimicrobial resistance is a glob...
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    TGA Pushes for Total Product Lifecycle Approach to Medical Device Cybersecurity

    New draft guidance from Australia’s Therapeutic Goods Administration (TGA) encouraged use of regulatory policies that span total product lifecycles (TPLC) to ensure medical device cybersecurity. A “growing area of interest” for TGA relates to “a large number” of class II, class III and active implantable devices registered in Australia that contain “electronic components with embedded software, have a software accessory or are a software device,” the regulator noted in ...
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    FDA Redrafts GMP Policies for Outsourcing Facilities

    The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance aims to clarify provisions that became applicable to outsourcing facilities, following the 2013 enactment of section 503B under the FD&C Act that allowed drug compounders to register as outsourcing facilities with FDA. Outsourcing facilities must be GMP compliant and are subject t...
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    Premarket Device Cybersecurity: Health Canada Issues Draft Guidance

     Health Canada posted a new draft guidance document on Friday to aid medical device manufacturers in complying with premarket cybersecurity requirements.   The move comes as more regulators seek to expand on considerations for the cybersecurity of medical devices as the health care sector became a prime target for cyberattacks amid an increasingly connected ecosystem.   The US Food and Drug Administration (FDA) issued premarket draft guidance for medical devices ...
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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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    AdvaMed, MITA Call for Tweaks to CDRH’s Proposed FY 2019 Guidance Development Lists

    Industry groups offered feedback on the lists of guidance the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) proposed to develop during this fiscal year. The comment period on the guidance development lists proposed for medical devices closed earlier this week, with AdvaMed and the Medical Imaging & Technology Alliance (MITA) among those that responded to the October call   for feedback. The groups addressed the list of guida...