• Regulatory NewsRegulatory News

    EMA Re-Elects Former MHRA Regulator to Lead Influential Management Board

    The European Medicines Agency (EMA) has announced the re-election of Sir Kent Woods as the chair of its influential 35-member Management Board, which sets regulatory policies for the agency. Woods, who served as chief executive at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) between 2004 and 2013 , will now serve as the board's chair for a final three-year term, after which time term limits preclude him from running again. Woods said in ...
  • Regulatory NewsRegulatory News

    FDA Finalizes IRB Transfer Guidance With Minimal Changes

    • 22 May 2014
    The US Food and Drug Administration (FDA) has announced the release of a final document intended to instruct sponsors, clinical investigators and institutional review boards (IRB) about how to transfer the oversight of clinical trials to a new IRB. The guidance, Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board , was first released in draft form in June 2012 by FDA and the US Department of Health and Human Servic...
  • FDA's Influential Science Board Seeks New Members

    US regulators are calling for new nominees to serve on the US Food and Drug Administration's (FDA) Science Board , an advisory committee charged with providing advice to the agency regarding science and technology issues impacting public health. The board has been highly influential on FDA in recent years. A landmark report issued by the committee in 2007 noted serious scientific deficiencies at the agency, and led to systematic changes meant to address the concerns. ...
  • EMA Management Board Turns Focus to Regulatory Science and Faster Approvals

    In its first meeting of 2013, the European Medicines Agency's (EMA) management board turned its sights on the agency's use of regulatory science, saying EU regulators need to adopt new approaches to allow for drugs to get to patients more quickly and with a better understanding of patients' tolerance for risk-a potential boon for members of rare patient populations. In a statement, EMA said the board has already turned its attention-much as the US Food and Drug Administr...
  • US Regulators Consider Formation of New Advisory Subcommittee to Study 'Data Liberation'

    The US Food and Drug Administration's (FDA) Science Board-an advisory board focused on the mission and competencies of the agency-will soon meet to start the process of reassessing a landmark 2007 report in which it described FDA as being in a state of decline. Background The report, FDA Science and Mission at Risk , was prepared in 2007 by the Science Board's Subcommittee on Science and Technology. In it, the board raised three principal points against FDA: that i...
  • Brazil Drops International GMP Inspection Proposal

    The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites. Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution. Moreover, elements of the earli...
  • Report Claims Staffing Problems Continue to Plague FDA

    The reputation of a federal agency often precedes it. For the US Food and Drug Administration (FDA), the public's perception of its reputation is proving to be a significant impediment to its attempts to recruit the best regulatory staff it can get, says a new report from the Partnership for Public Service (PPS). The group acts as a sort of advocacy group for those working in, or hoping to work in, the government. PPS said it had recently been approached by the Pew Cha...
  • FDA Science Board Seeks New Members

    US regulators are calling for new nominees to serve on the US Food and Drug Administration's (FDA) Science Board-an advisory committee charged with providing advice to the agency regarding science and technology issues impacting public health. In its 10 September Federal Register notice , FDA explains that the board is looking for those knowledgeable in a variety of fields, including pharmacology, translational medicine, clinical research, toxicology, biostatistics, m...
  • Agency Deficiencies Focus of Newly Proposed Scientific Subcommittee

    The US Food and Drug Administration's (FDA) Science Board will consider a motion to establish a new subcommittee at an October 2012 meeting that will seek to revisit some of the problems raised in a landmark 2007 report about scientific deficiencies at FDA. That report, FDA Science and Mission at Risk (2007), was prepared by the Science Board's Subcommittee on Science and Technology, and leveled three charges against FDA: Its scientific base is weak and eroding...
  • Brazil: Meeting to Discuss New Criteria for Therapeutic Indications

    The Board of Anvisa, the national regulatory authority of Brazil, is scheduled to review new regulations governing the format of "non-print" instructions for use of health products and the criteria for a therapeutic indication at its next public meeting. The Board will also receive a report by the Chief Executive Officer of Anvisa, Dirceu Barbano, on the international meeting of national regulators held in Geneva on 18 May that was organized by the agency on the topic of...
  • New Transparency Standards Now in Place for EMA's Management Board

    The European Medicines Agency (EMA) is on a transparency kick. After coming under unrelenting pressure from the European Parliament (EP) and other stakeholders over perceived opaqueness at the agency, EMA has recently moved to roll out a number of initiatives it says it hopes will reverse the notion that it is a closed agency. Now, its transparency efforts are going right to the top. In an announcement made 8 June, EMA said its Management Board will now be subject to...
  • Irish Medicines Board Announces Transition to Fully Electronic Submission System

    • 14 May 2012
    The Irish Medicines Board (IMB) is announcing its adherence to a 2005 agreement between the Heads of Medicines Agencies to transition to a fully electronic system for submitting applications, including the electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS). IMB said in a statement the transition confers several advantages, including reduced costs, consistency of applications and information viewed across agencies, improved lifecycle ma...