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    How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006 (Part 2)

    This two-part series provides insights into the new paradigm of biosimilar medicines based on approval and medical experience postapproval. It proposes a framework for the understanding, development and acceptance of a new generation of biologic medicines, biosimilars, in the US and worldwide. 1-3 Currently, the knowledge gathered by regulators and industry permits a degree of confidence in biosimilars authorized in the EU after nearly six years of pharmacovigilance, pr...
  • FDA Enacts New Class-wide REMS Policies for Opioids

    The US Food and Drug Administration (FDA) announced 9 July the approval of a new Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products. The new REMS policy will cover all extended-release (ER) and long-acting (LA) opioid products, and will rely primarily on educational products, which the m...
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    Innovation Leads to Transformation in Regulatory Agencies' Evaluation of Benefit-Risk

    Several innovations are currently being discussed or implemented by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). One key innovation area is the assessment of a medicinal products benefit-risk. A major focus is assessment of whether drug, device and biologic products have an appropriate benefit-risk balance for marketing approval and continued marketing. Recent International Conference on Harmonisation (ICH) guidelines, European legi...
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    Risk Management for Medical Devices - A Practical Approach

    Imagine yourself in this situation: you just started working for a new company and you review the risk management file you need to include in the next device submission, which, by the way, is urgent. You have a look at the Design History File (DHF). There is an FMEA you hope is up-to-date; a risk management plan that unfortunately lacks typical deliverables and a method for systematically tying together risks, hazards, requirements, controls, verification and validation ...
  • EMA Slams Roche Over Extensive Safety Reporting 'Deficiencies'

    The European Medicines Agency (EMA) released a statement on 21 June slamming Roche for alleged deficiencies in the company's medicines safety reporting, saying it had been made aware a cache of 80,000 potential adverse event reports that the company had failed to evaluate and submit to EU regulators. The allegations stem from a May 2012 report by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which had inspected the company under a routine inspection ...
  • Study Calls for Additional Regulation of Package Labeling

    To hear Laura Bix's analysis, it's a wonder more people aren't hurt each year by the medications they take. In a study published in the online medical journal The Public Library of Science: One , Bix, an associate professor at Michigan State University, and colleagues looked at how consumers analyze information presented on drug labels in the form of additional prescription drug warning labels (PWLs)-the small stickers on drug packaging imploring you to take heed of imp...
  • Blood Product Guidance Amended to Reflect New Disease Transmission Risks

    The US Food and Drug Administration (FDA) has released new guidance detailing how sponsors should include additional warnings on their products to reduce the risk of the transmission of Creutzfeldt-Jakob Disease (CJD). FDA last released a guidance on the topic in 2010, which made recommendations for labeling plasma-derived products to reflect the risks of CJD, which is a form of transmissible spongiform encephalopathy (TSE) spread through prions.  In its 11 June F...
  • FDA Looks to Reassess Hydrocodone Products

    The US Food and Drug Administration (FDA) is planning to revisit a benefit:risk assessment for a powerful painkiller subject to escalating amounts of addiction and abuse after the agency was pressed by a national drug control agency. In an 8 June Federal Register posting, FDA said it had been petitioned by the US Drug Enforcement Agency (DEA) to look at how the government classifies hydrocodone, which is subject to restrictions under the Controlled Substances Act (CSA...
  • MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children

    Some medicines approved to treat attention deficit hyperactivity disorder (ADHD) in the UK will soon include information in the patient information leaflet specifically targeted towards those under the age of 18 thanks to a partnership between regulators, academia and industry. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced Thursday, 7 June it is moving to implement the new information layout-reportedly the first time it has been done in th...
  • 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. ...
  • Report: REMS Preventing Companies From Making Generic Medicines

    The Food and Drug Administration (FDA) Amendments Act of 2007 allowed FDA to institute risk management plans-known as Risk Evaluation and Mitigation Strategies (REMS)-for products with a high probability of misuse or dangerous side effects. Now, manufacturers of generic medicines are claiming a side effect of the REMS policy is just as dangerous: restrictive REMS policies are preventing them from obtaining samples of medicines they need to make generic copies. The ...
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    How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006

    This is the first of a two-part series on the pre- and postapproval clinical safety of known EU-approved biosimilar therapeutic protein medicinal products. It compares and contrasts EU experience with the long-awaited, overarching FDA biosimilars guidances. It also anticipates the safety of as-yet-unapproved potential biosimilars, including the recombinant mAbs, insulins, heparins and interferons. Biosimilar medicinal development strategy, perception of general risk, int...