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  • Regulatory NewsRegulatory News

    CDRH to Review Materials Used in Medical Devices

    Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.   “Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requi...
  • Regulatory NewsRegulatory News

    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
  • Feature ArticlesFeature Articles

    The Life and Times of a Promotional Claims Compendium

    This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization. Introduction Reviewing promotional materials is a necessity in the pharmaceutical industry. Rules and regulations implemented by the US Food and Drug Administration (FDA) regarding pro...
  • Regulatory NewsRegulatory News

    FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution. FDA first approved Fenwal's new drug application (NDA) for InterSol (500mL platelet additive solution 3) in 2009 as a storage solution to replace a portion of the plasma in platelets collected via the company's Amicus apheresis devi...
  • Regulatory NewsRegulatory News

    FDA Making Changes to its Drug Advertising Review Process

    A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional materials for review by regulators. Background At present, all pharmaceutical advertisements aired or distributed by companies must be submitted to FDA's Office of Prescription Drug Promotion (OPDP)—formerly known as the Division of Drug Marketing, Advertising and Communication...
  • Regulatory NewsRegulatory News

    FDA Looking for a Leader for its New Device Testing Division

    The US Food and Drug Administration (FDA) is on the hunt for a new leader for its device center's newly formed Division of Biology, Chemistry and Materials Science (DBCMS). The new division, housed within the Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Laboratories (OSEL), is primarily concerned with how medical devices physically interact with patients. For example, its staff will be assessing devices for biocompatibility, biolo...
  • Regulation, Security of Nuclear Materials Used in Health Products Questioned

    US Nuclear Regulatory Commission (NRC) rules governing how radioactive materials are stored and secured are coming under additional scrutiny after a US Government Accountability Office (GAO) report showed physicians were largely untrained and unprepared to accommodate the materials. Radioactive materials are regularly used in medical devices and cancer treatment, and the security of those materials has generally fallen under the responsibility of hospitals. Post-9/11 con...