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  • EMA to Publish Scientific Opinions on Medicines Contained in Medical Devices

    The European Medicines Agency (EMA) will for the first time begin publishing public assessment reports (PARs) for pharmaceutical and biological medicines used in medical devices, the agency said in an 8 August announcement . The EU regulatory agency does not, to the consternation of critics , review medical devices. Devices intended for marketing in Europe are instead regulated through the European Conformity (CE) marking system, through which devices are assessed by e...
  • Continuing Transparency Push, EMA to Make all Meeting Minutes Public

    In a change with existing policies, the European Medicines Agency (EMA) announced Thursday, 19 July its plans to make all committee agendas and minutes publicly available by the end of 2013. The move is the latest in a flurry of recent moves by the agency to increase transparency after years of criticism regarding its perceived opaqueness. EMA coupled its announcement with a "first wave" of documents pertaining to the Paediatric Committee (PDCO) . The documents for that...
  • UK Proposes Reimbursement-based Accelerated Approvals Process

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is calling for comments on a newly-released proposal that would see some patients receiving medicines faster under an approval pathway focused more on reimbursement than on the complete assessment of a product's safety and efficacy. The pathway, called the Early Access to Medicines Scheme, "would provide a scientific opinion on the benefits and risks of medicines" from MHRA, which would in turn form the ...
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    Finding the Perfect Match: Mentors Guide Professionals

    Did you ever want career advice, but had no one to ask? Needed insight about informational interviews, but did not want to rely on the Internet? The RAPS Washington, DC/Baltimore Chapter hosted a "Mentor-Mentee: Match Making" event to bring together those seeking information with those who have it. Fourteen RAPS members participated at the RAPS training center in Rockville, MD on 21 June 2012. These individuals, representing the academic, not-for-profit, federal and c...
  • FDA Meeting on Hip Implants Recommends Against Use

    A panel of experts convened on Thursday, 28 June by US regulators has recommended against the use of metal-on-metal hip implants in patients, reports the Associated Press. The hips, cleared for use by the US Food and Drug Administration (FDA) through its 510(k) pathway which assesses products for "substantial equivalence" to existing products, have been increasingly under fire in recent months as safety concerns mount. UK regulators recently advised surgeons to stop im...
  • Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report

    A new government report looking at scientific disagreements within the US Food and Drug Administration's (FDA) medical device branch recommends a number of changes at the agency after a series of high-profile disagreements between staff brought on unwanted media attention. The report, by the US Department of Health and Human Services' (DHSS) Office of the Inspector General (OIG), looked at a population of 36 reported scientific disagreements occurring at FDA's Center for...
  • EMA Issues Guidance for Companies Seeking Scientific Advice

    The European Medicines Agency (EMA) has released revised guidance to answer questions about the process of seeking scientific advice from the agency, including an overview of the scientific advice process and how to prepare a request for scientific advice. EMA's Guidance for Companies Requesting Scientific Advice , the third revision of which was released on 15 May 2012, covers pre-submission meetings where companies request guidance from EMA staff on scientific issue...
  • IOM Issues Report on Studying Safety of Approved Drugs

    The Institute of Medicines (IOM) has released a consensus report on ways to improve the US Food and Drug Administraiton's (FDA) oversight of the safety of already-approved drug products. The report, entitled Ethical and Scientific Issues in Studying the Safety of Approved Drugs , explores a paradox often faced by FDA: only products that are safe should be approved, but the true safety profile of a product is difficult to ascertain until it has been used in real-world co...
  • EMA Publishes Updated Guidance on Premarketing, Postmarketing Procedures

    The European Medicines Agency (EMA) has released updated guidance on procedural advice for its post-authorization and pre-authorization procedural advice, providing regulatory professionals with comprehensive and integrated lists of the answers to most questions regarding the authorization procedure. EMA's 26 April guidances cover questions and answers applicable to the pre- and post-submission timeframes, and are frequently updated. Read more: European Medicines A...
  • Report: FDA Developing UDI Barcode System for Medical Devices

    A report in The Wall Street Journal and The Gray Sheet indicate the US Food and Drug Administration (FDA) is working to develop and roll out a Unique Device Identification (UDI) system. The policy- long in development and long held-up at the White House's Office of Management and Budget (OMB)-was mandated under the Food and Drug Administration Amendments Act (FDAAA) and is intended to standardize how medical devices are tracked. FDA has been attempting to harmo...
  • EMA Launches New Board to Coordinate Committees' Scientific Standards

    The European Medicines Agency (EMA) announced the launch of a new Scientific Coordination Board (SCB) which is intended to coordinate the development and implementation of standards between its committees. The board, which was announced 25 April, aims to make it "so that the standards they set for the development of medicines are consistent across the whole product life-cycle, for increased robustness and predictability of benefit-risk assessment," EMA said in a statemen...
  • EMA Posts Revised Integrated Guidance on Use of Centralized Procedure

    The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure. EMA's 18 April revision of the Q&A document represents its 21 st revision, and is a comprehensive resource including information from a wide range of regulations and guidances. "This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization procedures," ex...