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    Senators Look to Overhaul Medical Device Inspections

    Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers. Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings. "The current device facility inspection process lacks transparency, predictability an...
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    EMA Outlines GCP Inspection Plan for 2017

    The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections. Among other expectations for the coming year, the EMA’s GCP Inspectors Working Group will develop new and revised guidelines on the redaction of inspection reports to protect personal data and commercially confidential information, as well as ...
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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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    Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

    A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety. Back in 2008, FDA opened its first foreign offices as part of its res...
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    FDA and MHRA Break Down Foreign Inspection Data

    Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics. On FDA’s side, investigators conduct on-site inspections of regulated foreign establishments to proactively ensure the safety and efficacy of products manufactured abroad and sold in the US. In FY 2016 , FDA conducted 78 foreign inspections of human dru...
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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...
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    Japan Joins International API Manufacturing Inspection Program

    Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs). “PMDA has decided to join this program from 24 November 2016,” the agency said in an announcement. “The participation in...
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    Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DTAB Proposes Stipulations to Indian Plan for Permanent Licenses The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCG...
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    FDA Calls on Pharma Companies to Join Manufacturing Inspection Program

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes. The program, which aims to bring groups of OPQ staff to observe operations of commercial manufacturing, pilot plants and pharmaceutical test...
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    US, EU Look to Mutually Recognize GMP Inspections by January 2017

    The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP). Progress on mutually recognizing GMP inspection has been ongoing since June , particularly as the US Food and Drug Administration (FDA) has observed at least eight audits since 2014 and as six additional aud...
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    FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

    The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events. Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital , for their failure to keep written medical device reporting procedures and to repo...