• Biotechnology Companies Seek Changes, Clarification in Biosimilar Draft Guidance

    The US Food and Drug Administration's (FDA) draft guidance on biosimilars attracted general praise and some pointed criticism at a public meeting held 11 May as companies jockeyed for more flexibility and clarification, reports Genetic Engineering & Biotechnology News (GEN) . The meeting drew a huge amount of testimony, presentations and general comments from a host of companies and organizations , including Abbott, Amgen, Novo Nordisk, Pfizer, PAREXEL, BIO, Eli ...
  • FDA Issues New Draft Guidance on Pediatric X-Ray Imaging

    The US Food and Drug Administration (FDA) announced it is releasing new draft guidance for industry on what information needs to be contained with a company's premarket notification for any x-ray device intended to be used in pediatric populations. "FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging d...
  • FDA Looking to Develop Further REMS Guidance, Release Issue Paper

    The US Food and Drug Administration (FDA) is planning a workshop to gather feedback and information it can use to develop guidance for industry on the best practices for assessing goals associated with Risk Evaluation and Mitigation Strategy plans. The workshop, announced in a 2 May Federal Register posting, will take place on 7 June 2012. "The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, th...
  • Brazil: New Board Procedures Established For Oral Arguments

    Major changes to the way ANVISA Board meetings are run were published on 25 April ( Ordinance 616/2012). Companies in the regulated sector will now have two ways to comment during the open phase of the Board meeting: They may request the opportunity to present oral arguments concerning administrative appeals or ask for an opinion. Requests for oral argument must be submitted at least two days before the scheduled Board meeting and if the applicant wishes to have t...
  • FDA Plans Meeting to Explore Ways to Involve Patient Advocacy Groups in Regulatory Decision-making

    The US Food and Drug Administration is announcing its intent to hold a meeting on how best to involve patients, patient advocacy groups and health professional groups in regulatory decision-making. The meeting, FDA's first Patient Network program Annual Meeting entitled "Input into FDA Benefit-Risk decision-making: Opportunities and Challenges," is being hosted by FDA's Office of Special Health Issues and will be held on 18 May 2012. FDA said in a statement, "the meetin...
  • EMA Releases Presentations, Videos from Pharmacovigilance Stakeholder Meeting

    The European Medicines Agency (EMA) today (2 April) released video and presentations from its fourth stakeholder forum on the implementation of the new pharmacovigilance legislation. The meeting was held 27 February 2012, and heard presentations from members of EMA, the European Commission, the Irish Medicines Board, the Finnish Medicines Agency and the Medicines and Healthcare products Regulatory Agency. The presentations included: Welcome and introduction - June...
  • FDA Plans Meeting on Metal-on-Metal Hip Implants

    The US Food and Drug Administration (FDA) announced it is looking to hold a two-day meeting on implantable metal-on-metal (MoM) hip implants, saying it wants public input on whether to make the devices subject to more rigorous testing. "Numerous recent publications, studies and registry reports have raised safety concerns for MoM total hip replacements," said FDA in the Federal Register posting, including reports from the UK's Medicines and Healthcare products Regulato...
  • IMDRF Announces Open Stakeholder Meeting

    The International Medical Device Regulators Forum (IMDRF), the regulators-only successor organization to the Global Harmonization Task Force (GHTF), is announcing an 'Open Stakeholder Session' being held in September in Sydney, Australia. The Open Stakeholder session will take place on 26 September 2012, in the midst of IMDRF's three-day Australia meeting. According to IMDRF's website , the stakeholder meetings are meant to be a "structured dialogue between the IMDRF ...
  • Medical Device User Fee Act Released For Public Comment

    The proposed recommendations for the Medical Device User Fee Act ( MDUFA ) were cleared by the US Office of Management and Budget this week, clearing their way for release by the US Food and Drug Administration (FDA) and a 30-day public comment period. The FDA released a notice for the comment period and a public meeting on 15 March including the most recent MDUFA minutes, FDA's MDUFA commitment letter, pre-recorded video presentations and the text of the proposed ...
  • IMDRF Concludes Inaugural Meeting, Looks to Assume GHTF Duties

    The International Medical Device Regulators Forum (IMDRF), the regulators-only presumed successor organization to the Global Harmonization Task Force (GHTF), concluded its first meeting on 1 March. Roughly 100 participants were involved in formulating operational plans, planning the transition of GHTF functions to IMDRF, adopting a work plan and engaging in dialogue. IMDRF members seem to be grappling with how much value to place on existing GHTF output, including GHTF...
  • FDA Seeks Input on Next ICH Steering Committee Meeting

    The US Food and Drug Administration (FDA) is seeking input on the next meeting of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) meeting to be held in Fukuoka, Japan. FDA currently participates in the ICH by way of its Centers for Drug Evaluation and Research and Biologics Evaluation and Research. It is looking for public participation in the topics to be discussed at the upcoming meeti...
  • FDA to Hold Meeting on Modernizing Clinical Trials Regulation

    The US Food and Drug Administration (FDA) is set to hold a two-day meeting 23-24 April 2012 on how best to modernize the regulations, policies and practices associated with conducting clinical trials . FDA notes that "effective regulatory oversight is needed to ensure that human subjects are protected and resulting clinical trial data are credible and accurate." In response to complaints that current clinical trial regulations are inefficient, costly and outdated, FDA ...