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    FDA Warns BD for GMP Violations at Lock Flush Syringe Facility

    The US Food and Drug Administration (FDA) has warned medical device maker Becton Dickinson (BD) for good manufacturing practice (GMP) violations at the company’s Franklin, Wisconsin facility.   The warning letter comes after two-and-a-half-month inspection this summer during which FDA found the company’s pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe products to be adulterated.   The warning is BD’s second in 2018 after...
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    FDA Warns Datascope Over QSR, Reporting Violations

    The US Food and Drug Administration (FDA) sent a warning letter to New Jersey-based medical device maker Datascope Corporation over quality system regulation (QSR) and medical device reporting (MDR) violations.   Datascope, which was bought by the German multinational Maquet in 2008, markets a variety of cardiovascular devices such intra-aortic balloon catheters and cardiopulmonary bypass tubing packs.   The warning letter comes after an inspection of the company's...
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    FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices

    The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years. A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Ag...
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    FDA Plots New Enforcement Approach for Homeopathic Products

    The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic. The agency says it will begin prioritizing enforcement actions against such homeopathic products with reported safety concerns, intended for preventing or treating serious or life-threatening diseases and products aimed at vulnerable populations, among others. However, without new Co...
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    FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts

    The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C. Becky Wood, chief counsel for FDA, keynoted the conference and discussed the opioid crisis, and in particul...
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    Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months. Officials at TGA are ...
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    Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Sets Guidelines for FDC Trials as Long Wait for Phase IV Protocols Continues The Drug Controller General of India (DCGI) has outlined how makers of fixed-dose combinations (FDCs) can meet regulatory demands for clinical data on their drugs. DCGI Dr. GN Singh is asking FDC manufacturers to focus on safety data and is providing flexibility in the design of clinical...
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    Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Shares Flurry of Proposals to Encourage Drug, Medical Device Innovation The China Food and Drug Administration (CFDA) has released four draft documents intended to encourage innovation in the drug and medical device industries. CFDA’s proposals aim to cut the time it takes to set up a clinical study, accelerate the approval process, overhaul the patent system and...
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    Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...
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    China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications

    China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday. At least part of the problem stems from the fact that CFDA uses “an overly strict approach” for approving clinical trial applications, which contrasts with a...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Security of Connected Devices (31 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Security of Connected Medical Devices China Food and Drug Administration (CFDA) has released guidance on the security of connected medical devices. The guidance details the factors companies should consider when seeking to register a device with data storage and exchange capabilities for sale in China. CFDA is aiming the guidance at Class II and...
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    Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Ends OTC Status of Codeine Drugs Following Review The Therapeutic Goods Administration (TGA) of Australia has reclassified codeine-containing drugs as prescription-only medicines. TGA decided to prohibit over-the-counter (OTC) sales of products containing codeine after reviewing the safety and efficacy of the painkiller and assessing how it is handled by foreign r...