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  • FDA Issues New Drug Labeling Recommendations Intended to Avoid Medication Errors

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry recommending changes to the way companies place safety information on container labels and cartons, saying the changes are intended to reduce the number of medication errors. Background A 2006 report by the US' Institute of Medicine (IOM), a government think tank of sorts focused on healthcare, found that a major source of medication errors could be attributed to product labeling. ...
  • Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data

    A new report published by the US government Accountability Office (GAO), a intra-government watchdog that assesses programmatic weaknesses, has informed the US Food and Drug Administration (FDA) that it could be doing a better job at utilizing the information it collects on adverse events for dietary supplement products. Background The 18 March 2013 report reflects a complicated regulatory area for the agency, in which products-some of which contain pharmaceutical or ph...
  • Ruby Red and Regulatory: How a Modified Grapefruit could Help Sponsors of Drug Products

    When drugs are being reviewed by regulators, they are assessed for what risks they might pose to consumers. Those risks, once identified, can be dealt with in one of three ways: They can be designed out of the drug through a reformulation or the use of new excipients, consumers can be made aware of the risk through labeling, or consumers can be restricted from accessing the drug in an attempt to mitigate the risks. But what if a fourth option-the elimination of the risk ...
  • Canada Implements New Labeling Update Process for Generics

    Health Canada has announced that generics companies will have soon have timely access to new safety-labeling changes made to the Product Monographs (PM) for Canadian Reference Products (CRPs), pursuant to a Notifiable Change or Supplemental New Drug Submission made by a branded pharmaceutical company. The changes, announced 21 February 2013, is intended to improve timeliness of information in order to facilitate the required corresponding updates to generic PMs.  ...
  • How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

    What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon have a private-sector solution to improve their ability to ensure their medicines are of sufficient quality and identity. That initiative, run by the Partnership for Safe Medicines India Initiative (PSMII), is a side project of the Partnership for Safe Medicines-a coalition ...
  • New Regulatory Tools Requested to Study Messaging of Regulators, Industry

    How does a regulatory agency best communicate and regulate essential messaging to stakeholders on a continual basis without being ignored? The US Food and Drug Administration (FDA) isn't necessarily sure, either, and is looking to the private sector for answers. Writing on the Federal Business Opportunities website on 4 January 2013, FDA released an addendum to an earlier contact solicitation in which it sought the expertise of an outside firm to assist it in advancing...
  • Overestimated Efficacy, Underestimated Risks Guide Patient Treatment Options

    • 13 November 2012
    Patients and physicians alike often have lofty expectations and aspirations about the effectiveness of a prospective treatment. But, as a new article in the Annals of Family Medicine argues, those expectations contribute significantly to both the increasing costs of healthcare and avoidable harms suffered by patients. At the core of the healthcare cost crisis right now is an unavoidable fact, writes Steven Woolf, MD: The cost of obtaining healthcare, and in particular ...
  • Regulators: Need to Pay More Attention to Regulatory Capacity of Developing World

    • 24 October 2012
    Little attention has been paid to the regulatory systems in low- and middle-income countries across the world, causing a huge and negative impact on global public health, argue three employees of the US Food and Drug Administration (FDA) in the latest issue of the Public Library of Science Medicine (PLoS Medicine) . The article, Strengthening Medical Product Regulation in Low- and Middle-Income Countries , was authored by Charles Preston, Mary Lou Valdez and Katherin...
  • 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...
  • EMA Launches EU-Wide Investigation into Roche for Alleged Pharmacovigilance Deficiencies

    The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes. The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company ...
  • FDA Marks Half-Century of Regulation Based on Safety, Efficacy

    A half-century ago today, the US Food and Drug Administration (FDA) experienced perhaps its greatest expansion of regulatory authority since its inception, allowing it to regulate pharmaceutical products based not only on the safety of a product but their efficacy as well. That authority, granted by the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act of 1938, came in the wake of an international regulatory crisis involving Thalidomide, a drug in...
  • Countries Responsible for EU-wide Safety Monitoring Announced

    The European Medicines Agency (EMA) published on 5 October 2012 the first list of EU member states responsible for monitoring the safety of specific active substances across the EU.  In effect, each listed country will be responsible for monitoring specific medicinal products that have been approved for marketing in more than one EU member state through either the national, mutual recognition or decentralized procedures.  The monitoring data that each coun...