• Regulatory Considerations of Glaucoma Devices Focus of FDA Meeting

    Officials from the US Food and Drug Administration (FDA) are planning to hold a workshop in October to study the use, validity and reliability of medical devices used to image glaucomas, the agency announced in a Federal Register posting . A glaucoma is a type of eye disorder that negatively affects the optic nerve, usually because of increased pressure on the nerve, which can lead to worsened vision or blindness. In recent years, imaging devices have come to defi...
  • Proposed Medical Device Postmarketing Surveillance System Moves Forward

    Regulators with the US Food and Drug Administration (FDA) want to bolster the surveillance of already-approved medical devices, and are calling for public feedback on what the ideal system for conducting such surveillance might look like. In a 30 August Federal Register posting, FDA noted that, "Several high-profile device performance concerns have led some to question whether the Center for Devices and Radiological Health's (CDRH) current postmarket surveillance ...
  • FDA Wants New Study Data Exchange Format

    The US Food and Drug Administration (FDA) is calling for comments from industry and the public on the development of standards for study data exchange standards. In a 13 August 2012 Federal Register notice, FDA said it would be holding a meeting to assess the suitability of the current study data exchange format , the ASCII-based SAS Transport (XPORT) version 5 used by its drugs, biologics and devices regulatory centers. Though FDA said the standard has been in place ...
  • US Regulators, Defense Officials to Converge for Meeting on Blood Product

    US regulators are set to reassess the benefits and risks of hydroxyethyl starch (HES) solutions at an upcoming workshop co-sponsored by an unusual combination of federal agencies. Regulators from the US Food and Drug Administration (FDA) will join along with the Department of Defense (DOD), the National Institutes of Health (NIH)'s National Heart, Lung and Blood Institute and a wide variety of other participants from academia, industry and other stakeholders to discuss...
  • FDA Plans to Focus on Tablet Scoring, Nanotechnology at Upcoming Meeting

    • 13 July 2012
    The US Food and Drug Administration (FDA) plans to address tablet scoring and nanotechnology topics at an upcoming meeting in August 2012, the agency said. In a 13 July 2012 Federal Register posting announcing the meeting, FDA explained that the meeting's topics will include proposed draft guidance on tablet scoring released in August 2011 entitled, Tablet Scoring: Nomenclature, Labeling and Data for Evaluation . The draft guidance directs sponsors of New Drug Appl...
  • FDA Announces Planned Update to Electronic Common Technical Document

    The US Food and Drug Administration (FDA) announced its intent to hold a meeting to update stakeholders on the changes it plans to make to Module 1 of the Electronic Common Technical Document (eCTD), which is used to describe administrative and prescribing information for medicines. The eCTD is a standardized application form developed in conjunction with the International Conference on Harmonization (ICH) and its member parties. Both the Center for Drug Development and ...
  • FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve

    Review staff from the US Food and Drug Administration (FDA) said Edwards Lifesciences' Sapien Transcatheter Heart Valve (THV) met trial endpoints for safety and effectiveness for the treatment of high-risk severe aortic stenosis, but expressed concern about trial biases, long-term risks to patients and the statistical validity of some of Edwards' findings. Edwards' device is set to go before a meeting of the Circulatory Systems Advisory Committee on 13 June, where Edward...
  • 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...
  • FDA Looks to Reassess Hydrocodone Products

    The US Food and Drug Administration (FDA) is planning to revisit a benefit:risk assessment for a powerful painkiller subject to escalating amounts of addiction and abuse after the agency was pressed by a national drug control agency. In an 8 June Federal Register posting, FDA said it had been petitioned by the US Drug Enforcement Agency (DEA) to look at how the government classifies hydrocodone, which is subject to restrictions under the Controlled Substances Act (CSA...
  • FDA Announces New Meetings, Workshops

    The US Food and Drug Administration (FDA) announced three new advisory committee meetings and a new workshop in the Federal Register  on 23 May 2012. Regulatory Focus is pleased to present you with a brief summary of their respective topics. Meeting: Oncologic Drugs Advisory Committee The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test ...
  • World: Regulatory Agencies Attend WHO Seminar

    Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate. The meeting, an international seminar hosted by the World Health Organization (WHO), included representatives from Australia, Argentina, Brazil, France, India, Portugal, South Africa, the United States and the UK. A total of 30 regulatory agencies attended the meeting. The meeting coincided with the WHO'...
  • Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting

    The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve industry efficiency when conducting such trials. "The feedback may increase communication and collaboration within the stakeholder community, and, ultimately, help overcome some of the current challenges associated with designing clinical studies and generating clinical per...