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  • Regulatory NewsRegulatory News

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    Premenopausal women should be considered for inclusion in breast cancer clinical trials, according to new draft guidance from the US Food and Drug Administration (FDA). “Menopausal status should not be the basis of exclusion from any breast cancer clinical trial,” says the draft guidance, which was made available for a 60-day consultation period on 7 October.   The draft guidance puts forward recommendations to help move clinical breast cancer research away from the hi...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

    As part of a push to reduce administrative burdens, the US Food and Drug Administration (FDA) on Wednesday finalized guidance on an optional streamlined submission process for determining the risk of an investigational in vitro diagnostic (IVD) in a clinical trial where an investigational IVD is being co-developed with an oncology investigational drug. The submission process, first proposed in draft guidance in April 2018 , is meant to help sponsors determine if an IVD...
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    Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

    The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs, Ibrance (palbociclib) from Pfizer, Novartis' Kisqali (ribociclib) and Lilly's Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death. “We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall bene...
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    Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research

    As television ads for cancer drugs pose the question, “Who wouldn’t want a chance to live longer?” or present statements like: “Living longer is possible,” the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is trying to figure out if consumers can understand these drugs’ specific and often complicated indications supported by different types of endpoints. And now drugmakers Novartis, Merck and Eli Lilly are seeking modifications to ...
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    FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.   GnRH agonists and antagonists are a mainstay for treating patients with prostate cancer, FDA says, noting that it is one of the most common forms of cancer in American men.   “New drug applications for GnRH analogues typically rely, in part, ...
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    Pfizer Uses EHR Data to Support Expanded Indication for Breast Cancer Drug

    In a move that may become more common as the US Food and Drug Administration’s (FDA) comfort with real-world data (RWD) increases, FDA on Thursday approved a new indication for Pfizer’s Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with certain types of metastatic breast cancer. The approval is based on RWD from electronic health records and postmarketing reports of Ibrance in male patients sourced from three databases: I...
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    Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

    Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation. France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee doe...
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    Merck and PhRMA to FDA: Wait for ICH Before Finalizing Guidance on Toxicity Testing for Cancer Drugs

    Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to hold off on finalizing a draft guidance until the International Council on Harmonisation (ICH) finalizes its own guidance on the topic of reproductive toxicity testing for oncology drugs. Comments were released last week on the FDA draft guidance from late September. Industry group PhRMA and Merck both called on FDA to ensure consistency between the draft guidance and relevant I...
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    Drug Labels: Experts Note Importance of Faster Updates

    The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research's annual meeting in Washington, D.C. on Wednesday. Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), noted her agency has been working on the issue of label updates for a number of years, particul...