• Regulatory NewsRegulatory News

    FDA Warns Three Companies Over DTC Genetic Tests

    Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests. The letters are addressed to three companies: DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., which FDA says are marketing genetic tests to consumers without being cleared. In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnost...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China to Strengthen Oversight of Medical Device Manufacturing (13 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Details New Approach to Medical Device GMP in Four Guidance Documents China Food and Drug Administration (CFDA) has moved to strengthen its oversight of medical device manufacturing. The new approach is detailed in four guidance documents covering medical device good manufacturing practices (GMPs), in which CFDA explains its approach to on-site inspections. CFDA...
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    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
  • Feature ArticlesFeature Articles

    Fruit Flies––Powerful Foot Soldiers in Genetic Research

    “ Time flies like an arrow; fruit flies like a banana.”––Comedian Groucho Marx Most everyone knows fruit flies gravitate toward bananas and other overripe fruit, and almost magically appear in kitchens around the world. Less well known is the fact this insect species has been used for more than 100 years to study genetics and developmental biology. Perhaps the most remarkable discoveries in these fields have come from research with this persistent pest. Fruit flie...
  • EMA Publishes Pharmacogenetics Guideline for Evaluation of Medicines

    The European Medicines Agency (EMA) published a new guideline on the use of pharmacogenetics in evaluating pharmacokinetics of medicines on 10 February. The guideline provides specific requirements and recommendations for designing, conducting, dosing, and evaluating clinical studies. The guideline also discusses how to use information obtained in clinical studies for labeling and treatment recommendations. The guideline notes that "genetic variation can affect the ab...
  • EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation

    The European Medicines Agency (EMA) issued a concept paper on 23 January that calls for a new guideline to be issued on the use of pharmacogenomics in the conduct of pharmacovigilance. The concept paper notes that the response most individuals have to drug therapy is highly variable, and a prominent component of this variability is related to genetic variations. This can relate to drug disposition (pharmacokinetics) or drug action (pharmacodynamics). Accurate knowledg...