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  • FDA guidance addresses ultrasonic prostate ablation submissions

    A new final guidance from the US Food and Drug Administration (FDA) addresses clinical testing and clinical data collection to support marketing authorizations for high intensity ultrasound systems to ablate prostate tissue.   The agency clarified in the guidance that the scope is limited to clinical investigations that support authorization to market the devices for “general indications of prostate tissue ablation systems,” including those regulated under the PLP...
  • Feature ArticlesFeature Articles

    Update on RMAT designations

    This article discusses the scope and purpose of the special designation for regenerative medicine advanced therapies (RMAT) created by the passage of the 21st Century Cures Act. The authors explain the benefits expected to be realized with RMAT and provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   Introduction Section 3033 of the 21st Century Cures Act, titl...
  • Regulatory NewsRegulatory News

    Electronic device submissions addressed in FDA guidance

    A new final guidance from the US Food and Drug Administration (FDA) lays the framework for electronic submissions for medical devices. The agency advised that more specifics about the nuts and bolts of electronic submissions, as well as the timing of implemention, will be provided in upcoming guidances.   One guidance document is insufficient for describing and implementing electronic formats for all types of submissions covered under the statutory requirements, said F...
  • RoundupsRoundups

    FDA Approvals Roundup: Qwo, Tremfya, Dysport

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Qwo nabs approval for first injectable cellulite treatment Endo International’s Qwo (collagenase clostridium histolyticum-aaes [CCH] injection) has been approved as the first injectable therapy for moderate to severe cellulite in adult women.   The approval was based on findings from two identical double-blind, placebo-controlled trials in...
  • ReconRecon

    Recon: Moderna coronavirus vaccine yields immune response in Phase 1 trial; FDA panel backs GSK’s multiple myeloma drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna coronavirus vaccine shows promising results in early clinical trial ( Politico ) ( STAT ) ( Endpoints ) ( NYTimes ) ( In the Pipeline ) ( Financial Times ) FDA panel votes in favor of approving GSK's multiple myeloma drug ( Reuters ) ( Endpoints ) J&J's Tremfya Receives FDA Approval for Psoriatic Arthritis ( Press ) Fake pharmaceutical ad urges viewers...
  • Regulatory NewsRegulatory News

    Experts urge transparency, advisory committee review for COVID-19 vaccines

    At a virtual briefing on Tuesday, several experts told members of the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that a transparent process and advisory committee review will be key to the effective rollout of a vaccine to prevent coronavirus disease (COVID-19).   The briefing comes just two weeks after the US Food and Drug Administration (FDA) issued guidance on the development and licensure of vaccines against SARS-CoV-2, the...
  • Regulatory NewsRegulatory News

    FDA adds three tropical diseases to PRV list, rejects two

    Three new conditions were added today to the list of tropical diseases for purposes of obtaining a tropical disease Priority Review Voucher (PRV) from the US Food and Drug Administration (FDA). The agency added brucellosis to the list, as well as two foodborne trematode infections, opisthorchiasis and paragonimiasis.   The agency determined that two other diseases, coccidioidomycosis and clonarchiasis, did not meet statutory criteria for tropical disease designation un...
  • Regulatory NewsRegulatory News

    FDA updates COVID-19 therapeutics website

    The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner Stephen Hahn, MD and colleagues. Over 510 COVID-19-directed drug development programs have reached the planning stage.   In the blog, agency officials provide an update on FDA’s Coronavirus Treatment Acceleration Program (CTAP), a set of resources designed to allow cross-agency...
  • Regulatory NewsRegulatory News

    Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.   Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by h...
  • ReconRecon

    Recon: Moderna plans to start Phase 3 coronavirus vaccine study on 27 July; Roche, Blueprint partner on targeted cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vaccine-makers’ ‘no profit’ pledge stirs doubts in Congress ( Politico ) Moderna will begin late-stage coronavirus vaccine trial on July 27 ( CNBC ) ( Reuters ) US COVID-19 vaccine program to start manufacturing by late summer, says official ( Reuters ) ( Endpoints ) ( CNBC ) Hospitals Stock Up on Covid-19 Drugs to Prepare for Second Wave in Fall ( WSJ ) Blue...
  • Regulatory NewsRegulatory News

    Industry calls for IP protection, innovation support in EC pharmaceutical roadmap

    The European Commission (EC) has posted feedback it received on a new roadmap for a pharmaceutical strategy aimed at increasing timely patient access to affordable medicines. The feedback period began 16 June; a period of public consultation remains open until 15 September, with commission adoption planned for the 4 th quarter of 2020. Organizations leaving feedback generally welcomed the development of the roadmap, but many pharmaceutical manufacturers and trade assoc...
  • Regulatory NewsRegulatory News

    CBER withdraws 20 draft and final guidances

    Last week, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) withdrew 20 draft and final guidances, more than half of which date back to the 1980s and 1990s.   Many of the withdrawn guidances relate to blood and blood products, donor screening and HIV. Among the guidances are a Y2K-era guidance on handling the year 2000 date change for computer systems and software applications used to manufacture blood products and a 200...