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  • Regulatory NewsRegulatory News

    FDA issues at-home and OTC COVID-19 testing template

    Developers of COVID-19 diagnostic tests designed for at-home and over-the-counter use have a new template they can use to submit emergency use authorization (EUA) requests to the US Food and Drug Administration (FDA).   For at-home testing, the template includes recommendations for developers in the scenario where samples are collected, analyzed, and results returned without the sample being sent to a laboratory for analysis. Additional validation recommendations are...
  • Feature ArticlesFeature Articles

    Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

    This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical...
  • Regulatory NewsRegulatory News

    FDA revises draft PLLR guidance

    The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance providing recommendations on the content and format of labeling required under the pregnancy and lactation labeling rule (PLLR).   The draft guidance was first issued alongside the final PLLR in 2014, with the rule itself taking effect in June 2015. The PLLR revised labeling requirements under the 2006 physician labeling rule, to “provide a framework for clearly communicating information ...
  • Regulatory NewsRegulatory News

    FDA addresses endotoxin levels in investigational cancer treatments

    Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US Food and Drug Administration.   The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug. Specifically addressed are parenterally admi...
  • RoundupsRoundups

    FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tecartus okayed as first CAR-T therapy for MCL Kite’s Tecartus (brexucabtagene autoleucel), a customized, one-time therapy derived from a patient’s genetically modified T cells, has received accelerated approval for treating adults with relapsed or refractory mantle cell lymphoma (MCL).   It is the first chimeric antigen receptor T-cell (CAR...
  • ReconRecon

    Recon: Moderna eyes $50-60 price for COVID-19 vaccine; UK signs deal for Sanofi, GSK coronavirus vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna pitches virus vaccine at about $50-$60 per course ( Financial Times ) ( STAT ) Moderna Vaccine Test in Monkeys Shows Promise ( NYTimes ) Most voters say they'd rather wait for an effective coronavirus vaccine ( Politico ) Public Health Experts Fear a Hasty FDA Signoff on Vaccine ( KHN ) ‘Nobody Likes Me,’ Trump Complains, Renewing Defense of Dubious S...
  • Regulatory NewsRegulatory News

    Hahn says COVID-19 vaccines will be reviewed in ‘real time’

    At an event marking the launch of Moderna’s Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami on Monday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn repeated assurances that his agency would not cut corners in approving a COVID-19 vaccine.   Pfizer also announced on Monday that it would begin a Phase 2/3 study of its COVID-19 vaccine developed in partnership with BioNTech. Both companies say they plan to enroll 30,000 participan...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on multiple function device products

    A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.   The guidance addresses provisions of the 21 st Century Cures Act ( Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – an...
  • ReconRecon

    Recon: Pfizer, BioNTech begin pivotal COVID-19 vaccine trial; Drugmakers skip out on White House meeting

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers refuse to attend White House meeting after Trump issues executive orders on costs ( Politico ) ( Reuters ) Moderna, Pfizer start decisive COVID-19 vaccine trials, eye year-end launches ( Reuters ) ( NYTimes ) Pfizer-BioNTech begin late-stage study of lead COVID-19 vaccine candidate ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Pfizer shares rise afte...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA plans changes to assistive technology oversight

    Australia’s Therapeutic Goods Administration (TGA) is set to limit its definition of assistive technology to low-risk products to clarify which devices are subject to its oversight. TGA chose the revised definition despite a consultation revealing opposition to the change from some trade groups.   In September, TGA held a consultation to advance reforms proposed by the Expert Panel Review of Medicines and Medical Devices Regulation. The panel called for TGA to remove p...
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    RAPS' LatestRAPS' Latest

    13 Earned Regulatory Affairs Certification (RAC) in midst of COVID-19 pandemic; Many others opt for future test date

    Thirteen individuals passed the Regulatory Affairs Certification (RAC) exam during the recent spring exam period, RAPS announced today. More than 90% of those who had initially registered to take the exam in the spring transferred to a later exam period, as most RAC test centers were forced to close temporarily in response to the COVID-19 pandemic. Nearly all registrants opted to take the exam at some point, rather than cancelling. In May, RAPS announced a pilot progr...
  • Regulatory NewsRegulatory News

    Gene therapies: Industry asks for clarification on FDA’s sameness guidance

    Biotech companies and industry groups are raising questions about the US Food and Drug Administration’s (FDA) recent draft guidance on interpreting sameness of gene therapy products under its orphan drug regulations.   The draft guidance, issued for comment in January, explains how FDA intends to determine the sameness of two gene therapies intended for the same use or indication for the purposes of awarding orphan drug designation and exclusivity. (RELATED: FDA fina...