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    Premenopausal women should be considered for inclusion in breast cancer clinical trials, according to new draft guidance from the US Food and Drug Administration (FDA). “Menopausal status should not be the basis of exclusion from any breast cancer clinical trial,” says the draft guidance, which was made available for a 60-day consultation period on 7 October.   The draft guidance puts forward recommendations to help move clinical breast cancer research away from the hi...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

    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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    RoundupsRoundups

    Asia Regulatory Roundup: TGA Updates Guidance on the Testing of Biological Medicines

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Updates Guidance on the Testing of Biological Medicines   Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use of TGA in-house orthogonal testing methods and other changes.   TGA published the first, and until this week only, version of the guid...
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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...
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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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    FDA Panel Recommends New Postmarket Requirements for Breast Implants

    As part of efforts to make breast implants safer, the US Food and Drug Administration (FDA) should consider additional postmarket data reporting requirements on breast implant manufacturers, the agency’s General and Plastic Surgery Devices Panel suggested after a two-day meeting. On whether to remove textured breast implants from the US market as other countries have done, the panel argued data is lacking to support such a recommendation as it would reduce options for p...
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    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements. The warning letters were made public by FDA late Tuesday and sent to Sientra and Mentor Worldwide on Monday for being in violation of two of the seven requirements established as part of their devices’ conditional approvals. They underscore an emerging FDA enforcement trend around PA...
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    CDRH to Review Materials Used in Medical Devices

    Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.   “Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requi...