• Health, Defense and Industry Officials to Discuss Regulatory Challenges of Blood Products

    The US Food and Drug Administration (FDA) is planning to hold a meeting along with members of industry and various and diverse government agencies in April to work through issues related to the donation of blood and the regulation of blood products. The 10-11 April workshop, entitled "Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations," is intend...
  • IOM Report Calls on Global Regulators to Work Together to Address Threat of Counterfeits

    A new report just published by the US Institute of Medicine (IOM) and sponsored by the US Food and Drug Administration (FDA) finds that global regulators and regulatory systems need to do more to combat the rising tide of falsified and substandard medicines. Background Though the two terms-falsified and substandard-are often used interchangeably, there is an appreciable difference. A falsified medicine is one that claims to be one substance, but is fact another entire...
  • IOM Workshop Report Calls for FDA to Assess Products Based on Cost Effectiveness

    Even casual observers of US healthcare policy are aware of a common refrain: Costs are too high, unsustainable and a poor indicator for the quality US patients ought to be receiving. While the reasons for the high costs of healthcare are frequently and loudly debated, a new report out from the US Institute of Medicine (IOM), a venerable think tank of sorts that advises US agencies on matters of health, argues that at least some of those costs are the result of inefficient...
  • IOM Calls for Regulatory Harmonization

    • 28 November 2012
    The Institute of Medicine (IOM) wants the practice of regulatory affairs to be a little bit easier, particularly for low-resource countries and companies conducting international clinical trials. In an announcement on 28 November 2012, the prestigious healthcare agency said it plans to hold a meeting on regulatory harmonization, the process by which countries and organizations standardize their regulatory processes. IOM has long been interested in regulatory topics. W...
  • 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...
  • New Center could be Model for Advancing Regulatory Science, Cures

    A new draft report published by the US Institute of Medicine (IOM) on the so-called "Valley of Death"-the gap between therapies exhibiting promise and those actually being approved for use in patients-explores the possibilities for leveraging the newly formed Cures Acceleration Network (CAN). CAN was formed out of the 2010 Patient Protection and Affordable Care Act (PPACA) , and now resides within the National Institutes of Health's (NIH) National Center for Advancing...
  • Workshop Aims to Assess Emerging Field of Absorbable Medical Devices

    A new workshop sponsored by US regulatory officials will investigate the use of absorbable materials in medical devices and methods to predict their clinical performance. Writing in the Federal Register , the US Food and Drug Administration (FDA) said the devices have already shown potential, and noted the possibility of stents that could fully degrade within the body instead of requiring removal at a later point in time. Other devices could be partially absorbable, not...
  • FDA Announces Series of Workshops Looking at Clinical Trial Design

    The US Food and Drug Administration (FDA) has announced a series of public workshops aimed at addressing the design of clinical trials and the role of clinical and regulatory professionals. Kidney Transplantation An 11 September 2012 workshop held by the agency will discuss the clinical endpoints for products used during kidney transplantation, including drugs and therapeutic biologics. FDA said the workshop was specifically aimed at obtaining information about the,"V...
  • FDA to Assess New Regulatory Endpoints for Four Disease Areas

    The US Food and Drug Administration (FDA) has announced a four-day meeting to discuss clinical endpoints potentially capable of being used to support future drug development in four therapeutic areas. The 19-24 September workshop, entitled " Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) ," is intended to discuss issues related to endpoints for eosinophilic esophagitis, pediatric and adult inflammatory bowel disease (IBD) and parenteral...
  • 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...
  • US Agency Launches Investigation Into Veterinary Pharmaceutical Industry

    The US Federal Trade Commission (FTC) is announcing an investigation into competitive issues in the veterinary pharmaceuticals market after concerns were raised to it regarding the pricing of medications and possible anti-competitive issues. "American consumers spend a tremendous amount of money on medications for their pets every year," FTC Chairman Jon Leibowitz explained in a statement. "High prices on these medications mean that consumers have less money for necessit...
  • IOM Explores Regulatory Hurdles of Animal Research

    A new workshop summary from the Institute of Medicine (IOM) calls upon researchers to consider the judicious use of animals used in global neuroscience research. In its 29 May release of International Animal Research Regulations: Impact on Neuroscience Research , IOM's group of experts convened under the auspices of the Forum on Neuroscience and Nervous System Disorders note neuroscience research has specific and unique implications for animals used in research. The ...