• FDA Announces Meeting Intended to Start Standardization Process for REMS

    US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a series of tools required of some drugs by the US Food and Drug Administration (FDA) to control the potential risks associated with use of a drug product. Background REMS were first introduced under the 2007 FDA Amendments Act (FDAAA) , and were meant to act as a regula...
  • 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...
  • Meeting to Focus on Regulatory Paradigm of Developing, Evaluating ALS Therapies

    The US Food and Drug Administration (FDA) will soon hold a public meeting to obtain input on ways to enhance the development of new therapies to treat amyotrophic lateral sclerosis (ALS), better known as Lou Gehrig's disease. The condition affects patients by degenerating their nerve cells, causing a loss of muscle control over some of the body's key functions, including breathing and swallowing, ultimately causing death. At present, there is no known cure for the dise...
  • FDA Proposes 'New Pathway' to Approve Drugs for Unmet Needs

    The US Food and Drug Administration (FDA) plans to hold a public meeting in February to discuss the formation of a "potential new pathway" intended to bring to market new products aimed at treating serious or life-threatening conditions for which there is an unmet need. The new pathway seems likely to take advantage of FDA's new draft guidance on enriched clinical trials , which states that small, targeted subpopulations of patients may be used as the basis of approval ...
  • US Regulators Looking into New Prescribing Paradigm for Opioids

    US regulators are preparing to hold a meeting regarding the use of opioid drugs to treat chronic pain, and whether new restrictions on their use should be required. In the 19 December edition of the Federal Register , the US Food and Drug Administration (FDA) said that its meeting is meant to address-using scientific data rather than anecdotal reports-ways to minimize the improper use and abuse of opioid drugs while maintaining access for those who rely on the drugs...
  • 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...
  • Brazilian, Global Regulators Focus on Pharmacovigilance

    Together with the World Health Organization (WHO) and the Pan American Health Organization (PAHO), Brazil's National Health Surveillance Agency (Anvisa) recently hosted two international meetings on pharmacovigilance in Brazil, bringing together countries from Latin America and around the globe. Both meetings provided the opportunity to further integrate post-marketing surveillance activities in the Latin American and Caribbean region. Delegations from 59 countries, incl...
  • Meeting to Address Use of Clinical Outcome Measures for Orthopedic Devices

    US regulators plan to hold a workshop later this month to discuss the use of clinical outcome metrics for orthopedic medical devices. The 27 November workshop, co-sponsored by the US Food and Drug Administration (FDA) and the Georgia Institute of Technology's Translational Research Institute for Biomedical Engineering and Sciences (TRIBES), is focused specifically on two key topics: minimum clinically important differences (MCID) and patient-reported outcomes (PRO) instr...
  • Brazilian Regulators: Development, Oversight of Nanotechnology Products a Priority

    Brazil's National Health Surveillance Agency (Anvisa) met on 31 October 2012 to discuss the potential impact of nanotechnology on various fields, including medicines and biology, and how the technology could be used to benefit the country's national strategic priorities on public health and industrial development. The use of nanotechnology has been associated with potential risks to human health, and Anvisa regulators made clear that the agency sees its role as both a ...
  • FDA Plans to Review REMS, ETASU Strategies for Teratogenic Products

    The US Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee (DSaRM) is preparing to meet in December to discuss risk management strategies for teratogenic products. Teratogens are most commonly pharmaceutical products which, when taken by a pregnant woman, can cause birth defects or other developmental abnormalities. One of the most notorious teratogens is Thalidomide, a drug used briefly in the 1950s and 60s to treat the effects of mor...
  • Republicans, CEOs Blast FDA's Medical Device Review Process

    Republican members of the House Energy and Commerce Committee (E&C) recently took aim at the US Food and Drug Administration's (FDA) medical device approval policies, calling for the agency to get products to market more quickly after hearing concerns raised by a number of executives. At a meeting with a handful of medical device CEOs entitled, " Jobs and Innovation Forum on Medical Devices ," the congressmen took aim at FDA, and in particular its medical device regu...
  • FDA, Others Plan Meeting to Address Antimicrobial Resistance

    Three US healthcare agencies, including the US Food and Drug Administration (FDA), are planning to hold a meeting in November on the topic of antimicrobial resistance, and in particular the progress made to combat resistance and further steps to be taken. The meeting, announced in a Federal Register posting on 19 September , will also involve the Centers for Disease Control and Prevention (CDC) and the National Institutes of health (NIH), all of which are located wi...