• RAPS' LatestRAPS' Latest

    Outstanding Contributions Deserve Outstanding Recognition

    Nominations are now open for RAPS awards, which go to regulatory professionals with diverse, global backgrounds. The RAPS Awards Committee is currently seeking nominations for RAPS' annual awards honoring outstanding regulatory professionals in the healthcare products sector. RAPS' awards programs provide an important opportunity to acknowledge outstanding individual contributors to the regulatory field. This year, the committee has made significant improvements to the...
  • FDA Establishes Class II Controls for Full Field Mammography System

    The US Food and Drug Administration (FDA) released new guidance on 27 March establishing Class II Special Controls for full field digital mammography systems (FFDMS), bringing the device class under the 510(k) approval pathway. The guidance, Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System , includes advice on the evaluating risks to human health, electrical safety precautions, biocompatibility, phy...
  • 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...
  • Following US, Canada Permits Unapproved Drugs Into Country To Ease Shortages

    Health Canada is allowing unapproved drugs into the country on a short-term, controlled basis in order to alleviate recent drug shortages, reports The Ottawa Citizen . "Under the special access program, the federal drug regulator has the power to grant the limited sale of unapproved drugs to physicians treating select patients with 'serious or life-threatening conditions,'" wrote The Ottawa Citizen . Health Canada has reportedly approved 17 requests under the special...
  • 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...
  • Investigation into FDA Handling of Whistleblowers Widens

    The US Office of Special Counsel (OSC) announced on 15 February that it had opened an investigation into the US Food and Drug Administration's (FDA) handling of whistleblower complaints made by employees of its Center for Devices and Radiological Health (CDRH). The new investigation adds to two already launched by members of Congress and a lawsuit filed by six of the whistleblowers in the US District Court in Washington, creating a situation that could become politicall...
  • Feature ArticlesFeature Articles

    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...