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    Vagal nerve stimulator for stroke rehab nabs FDA nod

    The first-ever vagal nerve stimulation system for chronic ischemic stroke rehabilitation has received approval through the US Food and Drug Administration’s (FDA’s) most stringent pathway.   The vagal nerve stimulation (VNS) system will be marketed by MicroTransponder as the Vivistim Paired VNS System. The device enters the market through FDA’s premarket approval pathway after receiving breakthrough device designation.   "People who have lost mobility in their hand...
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    CDRH Issues Guidance on Brain-computer Interface Devices

    Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...
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    A New Regulatory Paradigm for Medical Devices in India

    This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes. Introduction Medical devices are a multi-billion-dollar global industry with continuous growth opportunities due to advancements in technology and new innovations. However, innovations and new advancements do not always reach patients due to a lack of clarity related to the approval p...
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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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    EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CRO

    The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs. The review of the CRO by EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that data from studies conducted at two sites between June 2012 and June 2016 “are un...
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    Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (25 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Clinical Data Probe Triggers Investigations Into 11 Trial Sites, CROs China’s Food and Drug Administration (CFDA) has opened investigations into 11 clinical trial sites and contract research organizations (CROs) as part of a data verification drive initiated last year. The regulator suspects the sites and CROs generated fraudulent clinical trial data to support 27 new ...
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    French Regulators Raise Serious Concerns With Indian API Manufacturer

    France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries. In an inspection from 20 August, the French regulators uncovered significant deficiencies linked to “the vast majority of inspected areas” at Nandu’s Hubli, India site. In particular, the inspectors highli...
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    Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority

    A lack of quality assurance (QA) oversight, a refusal of an inspection by the US Food and Drug Administration (FDA) and a failure to commit to any corrective actions regarding current good manufacturing practice (CGMP) violations observed on an FDA inspection landed a Chinese company an FDA warning letter, and a statement of non-compliance and a ban for two Indian companies recently. The FDA  warning letter , dated 26 July for Tianjan, China-based Concept Products Limit...
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    Asia Regulatory Roundup: CFDA Looks to Resolve Vaccine Shortages (12 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls on Regional Regulators to Work to Resolve Vaccine Shortages The China Food and Drug Administration (CFDA) has called on its regional offices to take steps to resolve the country’s vaccine supply shortage. The request comes at a time when CFDA and the vaccine industry it regulates are adapting to the changes that were proposed in response to the scandal that rece...
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    MHRA Delays Nordic Pharma’s Attempt to Add New Indian CMO Site to Marketing Authorization

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced that it has put on hold the addition of Indian contract manufacturing organization (CMO) Akums Drugs' Haridwar-based site as a manufacturing facility for the marketing authorization of Nordic Pharma's hormone injection progesterone due to a lack of sterility assurance. An MHRA inspection of the site (its first inspection for the site) on 13 April revealed one critical and three major...
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    Asia Regulatory Roundup: Serious Injuries Linked to Devices in China Almost Double (31 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Reports Drop in Manufacturers Achieving Satisfactory Compliance Australia’s Therapeutic Goods Administration (TGA) has reported a sharp drop in the proportion of domestic manufacturers achieving satisfactory levels of compliance during inspections. In the second half of 2015, no more than 81% of inspections identified satisfactory levels of compliance, compared to...
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    CDSCO Offers Risk-Based Checklist for Indian Pharma Manufacturing Inspections

    India’s Central Drugs Standards Control Organization (CDSCO) on Thursday released a new draft checklist and evaluation tool for pharmaceutical inspectors of manufacturing sites in India. The checklist and tool will help CDSCO and state inspectors understand and collaborate on which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are compliant. “The inspections are planned to be carried out jointly by the CDSCO offici...