• EMA Issues Guidance on Risk Assessment of Potential Medication Errors

    The European Medicines Agency (EMA) is issuing new guidance focusing on the potential for newly-formulated or altered medicinal products to harm patients through substitution, mix-ups and errors. In a 4 June position paper, EMA notes products frequently come onto the market with changes made to a referenced drug. These changes can include variations to the formulation, presentation, route of administration, strength or composition and indications of a medicinal product. ...
  • Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions

    • 26 April 2012
    Comments on the US Food and Drug Administration's (FDA) Medication Guide requirements for prescription drug labeling indicate displeasure with the requirements, which are referred to as onerous, costly, excessive, poorly executed and otherwise burdensome. The comments, contained in FDA's Federal Register posting, entitled Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labelin...
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    Regulatory Environment Changes Affect REMS

    To maintain the appropriate regulatory strategy for a product, it is important to stay abreast of continuing changes in the regulatory environment and applicable regulatory requirements. Knowing when regulatory requirements have changed because authorities have deemed an alternative to be sufficient to achieve the same goals can reduce wasted effort and costs for sponsors. One US Food and Drug Administration (FDA) requirement that has undergone an important change is th...
  • FDA, ISMP Announce New Initiative to Reduce Medication Errors

    The US Food and Drug Administration (FDA) announced Monday (2 April) it has formalized an existing relationship with the Institute for Safe Medication Practice (ISMP) to help protect consumers from medication errors. ISMP, a Pennsylvania-based non-profit, is focused on ways to prevent medication errors through making changes to labeling, packaging, prescribing, dispensing and other communications in the dispensing process. ISMP already operates a national Medication Err...
  • Study: Poorly Written Medication Warnings Missed by Busy Doctors

    • 30 March 2012
    A new study conducted by the US Department of Veterans Affairs and the Indianapolis-based Regenstrief Institute has found medication alerts are overly-detailed, poorly targeted and often skipped over by busy doctors, reports Fierce Health IT . The study, published in the International Journal of Medical Informatics , followed 30 doctors, nurse practitioners and pharmacists. That group received 320 medication alerts-which are used to alert medical professionals to new s...