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    FDA to Study Whether Consumers Can Take More Complicated Info in Pharma TV Ads

    As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...
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    Dr. Khoo Teng Chuan, Co-Chair of the RAPS Pan Asia Advisory Committee, Dies at 56

    Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56. Most recently, Dr. Khoo worked as chief medical officer for the Singapore Clinical Research Institute, after joining the institute as senior vice president in 2010. In this role as chief medical officer, he worked closely with Singapore’s national agencies including the National Medical Research Council, Health Sciences Aut...
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    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...
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    ANVISA Extends Deadline for Technical Requirement Responses in Brazil

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions. ANVISA’s technical requirement response deadline, previously 90 days, has been extended to 120 days from confirmation of requirement receipt by applicants. The...
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    Company Challenges UK Clinical Trial Transparency Rules

    An initiative to increase clinical trial transparency in the UK is being challenged in court after a successful petition by a company that conducts clinical trials for the pharmaceutical companies, The Guardian reports. Background The Health Research Authority (HRA) is a recently launched branch of the UK's National Health Service (NHS), tasked with overseeing clinical research and making recommendations on how research is regulated. While HRA's main mandate is ...
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    Hong Kong Regulators Launch Voluntary Distributor Registration System

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Hong Kong’s Medical Device Control Office (MDCO), the region’s medical device market regulator, has set up a  voluntary listing and registration  option for device distributors. Distributors who apply for listing and registration will be searchable under the Medical Device Administrative Control System, the MDCO’s online portal that also ...
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    Major Changes Set for Taiwan’s Medical Device Registration Process

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei. The regulatory changes will take effect starting 1 July 2015.  First, TFDA will introduce a two-step review program for marketing authorization appli...
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    FDA Approving Most New Drugs and Biologics During Their First Review, Report Finds

    The US Food and Drug Administration's (FDA) is now approving more new drugs and biologics during their first review cycles than at any time since at least 2008, a new FDA-commissioned report shows. Background The report , conducted by the Eastern Research Group (ERG) on behalf of FDA, is focused on the fifth iteration of the Prescription Drug User Fee Act (PDUFA) , which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . P...
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    Japan Launches NIH Analogue

    Today marks the launch of Japan’s new Agency for Medical Research and Development (AMED), which will take on the role of leading research and development in the country through partnerships between universities and industry. The agency’s launch is part of a larger restructuring of Japan’s publicly funded research and development sector. Background AMED was created following the passage of two acts in 2014, The Act on Promotion of Healthcare Policy and the Act on t...
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    Health Canada to Stop Accepting Hard Copies of Class III, IV MDL Application and Fee Forms

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Canadian medical device market regulator Health Canada will stop accepting hard copies of some Medical Device License (MDL) application forms starting 1 April 2015, and will also require a separate fee form to be electronically submitted with application forms starting on that same date. According to an email notice sent out 18 March by H...
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    FDA Wants Public Input on How to Improve Drug Safety

    If you have an idea for what the US Food and Drug Administration's (FDA) pharmaceutical regulators should be working on, now is the time to speak up. In a Federal Register announcement on 19 March 2015, FDA said it "hopes to foster collaborations with external partners and stakeholders" to help address a long list of regulatory "needs and priorities" identified by its Center for Drug Evaluation and Research (CDER), which is in charge of regulating drug products. The...
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    South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown. Among the  proposed list of devic...