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  • Regulatory NewsRegulatory News

    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...
  • Regulatory NewsRegulatory News

    Report calls for limits on compounded bioidentical hormone therapy

    Evidence does not support the clinical utility of compounded bioidentical hormone therapies and their use should be limited to patients who cannot use products approved by the US Food and Drug Administration (FDA), according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).   FDA requested the NASEM review due to increasing popularity of compounded bioidentical hormone therapies (cBHT) combined with concerns over he...
  • Regulatory NewsRegulatory News

    Lawmakers ask FDA to outline COVID-19 vaccine approval process

    Key Democratic members in the US House of Representatives have called on Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.   In a letter dated 18 June, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairma...
  • Regulatory NewsRegulatory News

    FDA yanks EUA for serology test

    The US Food and Drug Administration (FDA) on Tuesday revoked the emergency use authorization (EUA) granted to Chembio Diagnostic Systems Inc. for its DPP COVID-19 IgM/IgG System based on several sets of data indicating that the test generates false results at a higher rate than expected. This is the first revocation of an EUA for a SARS-CoV-2 serology test during the COVID-19 public health emergency. The system in question is an antibody test for the novel coronavirus; ...
  • FDA warns breast implant manufacturers

    The US Food and Drug Administration (FDA) today issued warning letters to two breast implant manufacturers, Allergan and Ideal Implant. Each company was cited for different deficiencies. "The FDA's actions today are part of the agency's ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices," FDA officials said in a statement. "The FDA remains committed to thoughtful, scientific, transparent, public dialogue conc...
  • Regulatory NewsRegulatory News

    FDA lifts requirements for fever screening devices

    Telethermographic devices originally intended for industrial, construction and commercial use can be repurposed to assist in initial screening for fever and triage of individuals in high traffic areas such as airports and businesses under guidance issued by the US Food and Drug Administration (FDA). The guidance was issued for the duration of the public health emergency related to coronavirus disease (COVID-19). “The guidance may help address urgent public health con...
  • Regulatory NewsRegulatory News

    FDA eases entry for psychiatry apps during COVID-19 crisis

    To address mental health needs during the coronavirus disease (COVID-19) public health emergency, the US Food and Drug Administration (FDA) today announced it would relax certain premarket requirements for computer programs and mobile apps designed to support treatment of conditions such as depression, anxiety, obsessive compulsive disorder and insomnia. The guidance addresses Class II prescription-only devices and computer programs that support clinician-supervised out...