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  • After Supply Chain Breaches, FDA Looks to Better Communicate Risks of Counterfeits

    An upcoming advisory committee of the US Food and Drug Administration (FDA) is set to discuss how the agency can engage in best practices for communicating with health care professionals and others about the risks of counterfeit and unapproved drugs. Background US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop products before t...
  • FDA Re-Issues Final Guidance on Open Public Hearings, Following Unusual Process

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding open public hearing sessions at the agency's advisory committee meetings, but the process by which it was published is highly unusual under the agency's good guidance practice standards. Background The final guidance, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings , was first issued as a d...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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...