• 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 ...
  • 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...
  • 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...
  • New EMA Guideline on Real Time Release Testing

    The European Medicines Agency (EMA) released a final guideline on real time release testing (RTRT), aiming to provide better guidance for regulatory professionals to ensure their products consistently meet necessary specifications. "RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control," explained EMA ...
  • EMA Tightens Conflict-of-Interest Policies

    The European Medicines Agency (EMA) announced it will, effective immediately, be tightening its conflict-on-interest policies for scientific experts and members of advisory committees. The policy was announced 3 April after being endorsed by EMA's Management Board on 22 March 2012. "The updated policy gives clearer guidance on the involvement of experts in academic trials and publicly funded research," explained EMA in a statement. "It aligns restrictions for the differ...
  • Paper: Small Companies Need Regulatory Assistance from EMA

    The European Medicines Agency (EMA) needs to assist companies-particularly small businesses, academic institutions and charities-in the development of advanced-therapy medicines, claims a new paper written by members of the Committee for Advanced Therapies (CAT) in the journal Molecular Therapies . These smaller drug development entities often lack the resources necessary to "navigate regulatory procedures," including clinical trials and application submissions. The pa...
  • EMA Guide on Development of Novel Drug Development Methodologies Released

    The European Medicines Agency (EMA) released a new guidance on 26 January that addresses the development of novel methodologies in drug development, and how EMA develops qualification opinions and advice for scientific methods and protocols. The qualification process is a "new, voluntary scientific pathway leading to either a [Committee for Medicinal Products for Human Use (CHMP)] opinion or a Scientific Advice on innovative methods or drug development tools." The pr...