• Near Infrared Brain Hematoma Detectors Classified as Class II Medical Devices by FDA

    The US Food and Drug Administration (FDA) issued a final rule classifying Near Infrared (NIR) Brain Hematoma Detectors as class II medical devices requiring special controls on 22 March. The rule is in response to a petition issued by InfraScan Inc., which asked FDA to classify its Infrascanner Model 1000 device-previously found by FDA to be class III-as a class II device instead. FDA agreed with their assessment, and identified the inherent risks of the device and miti...
  • EMA Adopts Reflection Paper on Evaluating Clinical Trial Samples

    The European Medicines Agency (EMA) adopted a reflection paper that aims to provide quality systems guidance for laboratories in charge of analyzing and evaluating samples generated from clinical trials. Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples , adopted 28 February and released 20 March, intends to provide clinical laboratories "with information that will help them develop and maintain quality systems" that com...
  • FDA Releases New Veterinary CMC Guidance

    The US Food and Drug Administration (FDA) is releasing new guidance for industry for chemistry, manufacturing and controls (CMC) information relating to fermentation-derived products, including intermediates, drug substances and related drug products for veterinary medicinal use. The guidance "provides recommendations on what documentation to submit to support the [CMC] information" for veterinary products to the Center for Veterinary Medicine (CVM). "This information i...
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    Demystifying CMC Regulatory Strategy for Biologics - Part 3: An Effective CMC Regulatory Strategy Is Possible

    Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; 1 Part 2 examined the major differences between biologics and chemical drugs; 2 and Part 4 will examine the challenge of adventitious agent contamination control for biologics. Failures...