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  • Regulatory NewsRegulatory News

    FDA Lays Out Tech Modernization Action Plan

    As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US Food and Drug Administration (FDA) on Wednesday unveiled its Technology Modernization Action Plan (TMAP). Near-term modernization in computer hardware and software technologies are the focus of FDA’s TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that FD...
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    FDA Developing Guidance on Real-World Data Quality Issues, Officials Say

    As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products w...
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    Novartis Makes New Data Integrity Commitment

    Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on Monday that the company will be more proactive in reporting data integrity issues to the US Food and Drug Administration (FDA). “We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible all...
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    FDA Flags Incidents of Excess Radiation Exposure to Patients

    The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans. The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high lev...
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    FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products

    A little more than a year after pushing back the date by which combination product companies must comply with certain postmarket safety reporting (PMSR) requirements, the US Food and Drug Administration (FDA) on Tuesday extended the compliance deadline again. The updated guidance explains how FDA does not intend to enforce 21 CFR 4.102(c) and (d) (constituent part-based PMSR requirements), 4.104(b)(1) and (b)(2) (submission process for constituent part-based Individual ...
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    Australia Unveils Device Action Plan

    Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...
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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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    FDA Draft Guidance on Patient Experience Data Incomplete, Critics Argue

    Industry group BIO, the National Association for Rare Disorders (NORD) and the National Center for Health Research (NCHR) called for clarification on how regulators will use draft guidances proposed by external stakeholders on patient experience data. The comments on the US Food and Drug Administration (FDA) draft guidance from December 2018 on developing and submitting proposed draft guidances related to patient experience data showed some consensus around including ...
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    FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors

    Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices. On Thursday, the US Food and Drug Administration (FDA) issued an FDA safety communication, while the US Department of Homeland Security's (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory to flag cybersecurity vulnerabilities detected in...
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    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...
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    EU Taskforce of Pharma Regulators Issues its First Report on Big Data

    A European drug regulators’ taskforce on big data published its first report on Friday. The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) formed the HMA-EMA Joint Big Data Taskforce to harness the potential of data in development and oversight, starting with the new report. They examined clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real-world data (RWD) to inform the work and reach “an important mileston...
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    FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

    Patients and health care providers should know that the safety and effectiveness of robotically-assisted surgical devices for the prevention or treatment of cancer has not been established for use in the US, a US Food and Drug Administration (FDA) safety communication warned on Thursday. The safety communication urges caution when using robotically-assisted surgical devices for mastectomy and any other cancer-related surgery, citing the lack of FDA evaluation on use of ...