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  • Regulatory NewsRegulatory News

    CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices

    A little more than a year since the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) put the finishing touches on a new expedited review process for potentially life-saving medical devices and the agency has accepted almost 60% of the applications of those looking to be a part of the new program. Over the past year, CDRH has made 29 decisions on requests for designation into its voluntary Expedited Access Pathway (EAP) program, an...
  • Regulatory NewsRegulatory News

    New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices

    The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions. Background FDA's Center for Devices and Radiological Health (CDRH) has for several years been putting the finishing touches on two conceptually related guidance documents: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for U...
  • Regulatory NewsRegulatory News

    Pfizer Launches Expanded Access Program for Breast Cancer Drug

    The US Food and Drug Administration's (FDA) expanded access program, sometimes referred to as its "Compassionate Use" program, has frequently been in the news as of late, as dozens of patients have taken to social media in an attempt to pressure companies into allowing them access to clinical trials they believe might save their lives. But while many companies have seemed reluctant to grant access to those trials, pharmaceutical giant Pfizer is taking a markedly differen...
  • When are Postmarketing Trials Required for Medical Devices? New FDA Guidance Explains

    Earlier this week, the US Food and Drug Administration (FDA) launched the Expedited Access Premarket Approval program (EAP) , a new program aimed at getting innovative medical device products to needy patients more quickly by expediting the regulatory review of the products and their manufacturing processes. But in addition to the guidance document detailing the program, FDA also issued a draft guidance document on which clinical data FDA will expect companies to have a...
  • FDA Launches Long-Awaited Expedited Approval Program Aimed at High-Need Devices

    The US Food and Drug Administration (FDA) has released a long-awaited draft guidance document outlining an expedited approval pathway that can be used by sponsors of medical devices intended to treat life-threatening or "irreversibly debilitating" diseases or conditions. Background: EAP Basics The guidance, which for months has been rumored to be near completion , introduces the "Expedited Access Premarket Approval" program, or EAP for short. Regulatory officials said ...