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  • RoundupsRoundups

    FDA Roundup: Blenrep, Olinvyk, Lampit

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Blenrep okayed for multiple myeloma in heavily pretreated adults GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf injection) has received accelerated approval for relapsed or refractory multiple myeloma in adults with previous failed treatments, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody.   Blenrep ...
  • Regulatory NewsRegulatory News

    FDA finalizes recommendations for enrolling males in breast cancer trials

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance making recommendations to sponsors encouraging them to enroll male patients in breast cancer clinical trials.   The final guidance comes one year after the agency issued the draft version for comment and includes only minor changes from the previous iteration. (RELATED: FDA calls for men to be enrolled in breast cancer trials , 26 August 2019) .   As in the draft version, FDA explains that ...
  • Regulatory NewsRegulatory News

    Device importers' COVID questions answered by FDA

    The US Food and Drug Administration (FDA) has launched two new webpages related to medical device importation, registration and listing during the COVID-19 pandemic.   The first webpage addresses registration and listing of medical devices, answering frequently asked questions (FAQs) about what is required, and what procedures should be followed, during the pandemic.   In the question-and-answer format, FDA collates information and guidance documents pertinent to o...
  • ReconRecon

    Recon: US signs $1.5B deal for Moderna coronavirus vaccine; Mesoblast GVHD therapy faces clinical, manufacturing questions ahead of adcomm

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna Inks $1.5 Billion Coronavirus Vaccine Deal With US ( WSJ ) ( Reuters ) Vir Biotech to begin mid-to-late stage study of COVID-19 drug candidate in August ( Reuters ) The top-selling drugs in the US in 2019 ( Axios ) Out-of-pocket spending on specialty drugs dropped dramatically after states capped costs ( STAT ) Mesoblast faces FDA pushback over cell t...
  • Regulatory NewsRegulatory News

    Hahn: COVID-19 vaccine decision will be "deliberative"

    The commissioner of the US Food and Drug Administration assured physicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be “based on good science and sound data.”   “Nothing else will be used to guide our decisions,” said Stephen Hahn, MD, speaking at a virtual meeting held by the Reagan-Udall Foundation on 10 August.   Hahn delivered prepared remarks along with American Medical Association president Patric...
  • Regulatory NewsRegulatory News

    European Commission reviews impact of orphan, pediatric regulations

    The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be used to guide future legislative changes and shape the EU pharmaceutical strategy.   The more than 100-page evaluation reviews the positive impacts and shortcomings of the orphan regulation, Regulation (EC) No 141/2000 , and the pediatric regulation, Regulation (EC) No 1901/2006 , based on external studies and var...
  • RoundupsRoundups

    Asia-Pacific Regulatory Roundup: COVID-19 drives hard-line advertising enforcement at TGA

    Australia’s Therapeutic Goods Administration (TGA) has taken a hard-line approach to enforcing the rules on the advertising products to prevent, treat and diagnose COVID-19, according to an independent review commissioned by the agency.   The independent review was designed to assess the impact of advertising oversight triggered by the 2015 Expert Panel Review of Medicines and Medical Devices Regulation. Because it occurred during the first six months of 2020, it also ...
  • ReconRecon

    Recon: Russia approves coronavirus vaccine before Phase 3 trials; Bayer to acquire women’s health focused KaNDy therapeutics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump expected to give update on US COVID-19 vaccine development -White House ( Reuters ) Novavax expects it can meet US COVID-19 vaccine demand in 2021, executives say ( Reuters ) J&J eyes one billion doses of potential COVID-19 shot in 2021, weighs challenge trials ( Reuters ) Merck Bets On a One-Shot Vaccine in Race With Its Faster Rivals ( Bloomberg ) Mod...
  • Regulatory NewsRegulatory News

    FDA guides drug-drug interaction studies for therapeutic proteins

    A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins.   The guidance, issued jointly by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) recommends that sponsors use a “systematic, risk-based” approach to determine whether their therapeutic protein candidates for investigational new drug applications (IND...
  • Regulatory NewsRegulatory News

    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...
  • Regulatory NewsRegulatory News

    Marketing status notifications: FDA fills in details in final guidance

    The US Food and Drug Administration (FDA) on Monday finalized its guidance on marketing status notifications for new and generic drugs, clarifying its expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale.   Under the FDA Reauthorization Act of 2017 (FDARA), drugmakers are required to notify FDA regarding the marketing status of their approved new drug applicati...
  • ReconRecon

    Recon: Kodak $765M loan on hold; Gilead submits NDA for remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Chief is Caught Between Scientists and the President ( NYTimes ) FDA’s reopening plan will keep biologics labs shuttered far longer than other government labs ( STAT ) Eastman Kodak's $765 million US loan agreement on hold after recent allegations ( Reuters ) ( Politico ) Gilead files US marketing application for remdesivir ( Reuters ) FDA approves first ...