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    Premenopausal women should be considered for inclusion in breast cancer clinical trials, according to new draft guidance from the US Food and Drug Administration (FDA). “Menopausal status should not be the basis of exclusion from any breast cancer clinical trial,” says the draft guidance, which was made available for a 60-day consultation period on 7 October.   The draft guidance puts forward recommendations to help move clinical breast cancer research away from the hi...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

    Updated 29 September to add comment from CDRH official The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries...
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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 ...
  • FDA warns breast implant manufacturers

    The US Food and Drug Administration (FDA) today issued warning letters to two breast implant manufacturers, Allergan and Ideal Implant. Each company was cited for different deficiencies. "The FDA's actions today are part of the agency's ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices," FDA officials said in a statement. "The FDA remains committed to thoughtful, scientific, transparent, public dialogue conc...
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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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    Asia Regulatory Roundup: Australia Suspends Sales of Eight Breast Implants After Safety Review

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Suspends Sales of Eight Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) has suspended the sale of eight breast implants after finishing its review of the safety of the product class. The action gives affected manufacturers a chance to meet patient safety requirements, but TGA thinks there are likely grounds to perman...
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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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    RoundupsRoundups

    Asia Regulatory Roundup: TGA Proposes Ban on Certain Breast Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Ban on Certain Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) is planning to cancel the licenses of nine Natrelle textured breast implants made by Allergan. TGA proposed the action, plus the suspension of 16 other devices, after reviewing evidence of links between breast implants and a form of lymphoma.   Ove...