• Feature ArticlesFeature Articles

    In-house regulatory database development: Solution for a competitive oncology landscape

    The unprecedented number of new investigational agents in clinical development in the competitive oncology space presents a significant challenge for regulatory intelligence professionals. Strategic decisions are complicated by the overwhelming amount of regulatory information scattered across numerous repositories. The development of an in-house database may facilitate success for businesses in the prevailing information-centric world. Effective implementation of an in-ho...
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    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...
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    Groups suggest changes to FDA’s guidance expanding eligibility criteria for oncology trials

    While groups expressed overwhelming support for the US Food and Drug Administration’s (FDA’s) draft guidance expanding eligibility criteria for investigational oncology trials, some comments discouraged the agency from taking an approach that dichotomizes the curative and non-curative setting; a pharmaceutical firm suggested that safety data be combined for some investigations performed in curative and non-curative settings.   Among the recommendations of the draft gu...
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    FDA updates safety communication for robotically assisted surgical devices used in mastectomy

    The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to an updated safety communication released by the US Food and Drug Administration (FDA).   The agency reiterated that use of these devices has been cleared for procedures such as hysterectomy, prostatectomy, and colectomy based on data from 30-day patient follow-up. However, robotically assisted surgical (RAS) devi...
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    FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs

    The US Food and Drug Administration (FDA) "may require” or seek agreement from sponsors to conduct post-marketing studies to analyze long term effects of breast cancer drugs in both pre- and post-menopausal women in a final guidance issued on 17 June. The guidance also provides other considerations for sponsors as they plan for the inclusion of premenopausal women in clinical trials of drugs for breast cancer treatment.   According to the agency’s announcement of the f...
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    FDA modifies immunogenicity language in final bispecific antibody guidance

    A newly finalized guidance on bispecific antibodies from the US Food and Drug Administration (FDA) notes that although bispecific antibodies can generally be characterized in the same ways as standard monoclonal antibodies and manufacturing processes may be similar, some scientific and regulatory considerations are unique to bispecifics.   According to a 24 May agency announcement , while the regulatory pathway for evaluating monoclonal antibodies is “well established...
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    FDA clarifies deferral policy on pediatric studies for new cancer drugs

    Final guidance from the US Food and Drug Administration (FDA) specifies when sponsors must conduct pediatric studies for new cancer drugs as well as when those requirements can be waived or deferred.   Sponsors are required to evaluate these oncology drugs in pediatric populations for applications submitted on or after 18 August 2020, under changes made by the FDA Reauthorization Act of 2017 (FDARA).   The guidance addresses molecularly targeted oncology drugs for ...
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    HHS moves to end FDA’s unapproved drugs initiative

    Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs. FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs...
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    FDA: Include premenopausal women in breast cancer trials

    Premenopausal women should be considered for inclusion in breast cancer clinical trials, according to new draft guidance from the US Food and Drug Administration (FDA). “Menopausal status should not be the basis of exclusion from any breast cancer clinical trial,” says the draft guidance, which was made available for a 60-day consultation period on 7 October.   The draft guidance puts forward recommendations to help move clinical breast cancer research away from the hi...
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    FDA finalizes recommendations for enrolling males in breast cancer trials

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance making recommendations to sponsors encouraging them to enroll male patients in breast cancer clinical trials.   The final guidance comes one year after the agency issued the draft version for comment and includes only minor changes from the previous iteration. (RELATED: FDA calls for men to be enrolled in breast cancer trials , 26 August 2019) .   As in the draft version, FDA explains that ...
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    FDA Explains Levels of Impurity Found in Recalled Heartburn Drugs

    Following a series of recalls for the heartburn drug Zantac and other ranitidine drugs due to a genotoxic impurity, the US Food and Drug Administration (FDA) said Friday that the levels of the impurity in ranitidine drugs for heartburn and also in the chemically similar ulcer drug nizatidine “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” The agency also published a table of the ranitidine and nizatidin...
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    RWE to Supplement RCTs: FDA Projects Continue

    The US Food and Drug Administration (FDA) has been working with several different data and research companies to further its understanding of how real-world data (RWD) and real-world evidence (RWE) can help to inform its regulatory decision making. One such company that has signed an RWE research collaboration with FDA is COTA, Inc., which is working on a project related to replicating a breast cancer study. Andrew Norden, chief medical officer of COTA, told Focus ...