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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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    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
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    India’s Regulator Talks Improvements

    India’s drug regulator has struggled with criticism from inside and outside the country in recent years, but the agency wants the public to know it is taking steps to improve its performance. CDSCO’s Efforts In a post to its website today, the Central Drugs Standard Control Organization (CDSCO) lists nine areas it has worked on during the previous month. To combat the present outbreak of H1N1, also known as swine flu, CDSCO has taken measures to make sure drugs use...
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    Health Canada to Increase GMP Inspections, Promises Greater Transparency

    Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future. The move comes in the wake of an ongoing investigation by The Toronto Star , which has uncovered cases of data manipulation and unreported side effects at manufacturers supplying products to Canada. The paper made these revelations after obtaining inspection reports from the US Food and Drug Administration...
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    Study Claims German Dossier Requirements Could Improve Open Access to Trial Data

    A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports. The researchers, led by Beate Wieseler, head of the department of drug assessment at the Institute for Quality and Efficiency in Health Care (IQWiG), wanted to determine if the reporting requirements for early benefit assessment in Germany yielded more comp...
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    German Regulator Says EMA's Clinical Trials Transparency Definitions are Too Broad

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. German health technology assessment body IQWiG has criticized the European Medicines Agency's (EMA) clinical trials data transparency implementation plan, saying its definition of commercially confidential information is overly broad. In comments submitted to EMA, Beat...
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    DEA Scheduling Reform Bill Moves Forward in House

    The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly. Background The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
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    EMA Seeks Feedback on Clinical Trial Database

    In 2014, the European Medicines Agency (EMA) made headlines when it announced it would require pharmaceutical companies to report the results of their clinical trials. Now, in a new notice , EMA is asking for help in determining how it should make that information available to the public, including how it should balance transparency with confidentiality.      Background In April 2014, the European Parliament overwhelmingly passed its new Clinical Trial Regulation ,...
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    DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals

    The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA). Background In a notice posted to the House Energy and Commerce (E&C) Committee's website on 20 January 2015, Rep. Joe Pitts (R-PA) said he will hold a meeting on 27 January 2015 to consider several pieces of legislation, including the Improving Regulat...
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    The Case for Sharing Private Drug and Device Data

    A new report published by Georgetown University with support from a US Food and Drug Administration (FDA)-funded project calls for wider sharing of regulatory data in the hopes of enhancing the development of new products. Background The report, Facilitating Medical Product Development Through Voluntary Data Sharing , makes the argument that "wide sharing of research data would be good for scientific discovery and the enterprise of medical product development as well...
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    In Landmark Decision, EMA Adopts Clinical Trials Transparency Plan

    In a landmark decision with wide-ranging implications for drugmakers around the globe, the European Medicines Agency (EMA) has announced it will soon require pharmaceutical companies whose products are approved for sale in the European Union to make all clinical data supporting the approval of their medicines freely available to the public. Background As Focus explained earlier this year , EMA has for years been seeking a policy by which it could release patient-anon...
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    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...