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  • 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 ...
  • Regulatory NewsRegulatory News

    Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

    President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.   Speaking at a Whirlpool Corporation manufacturing plant in Clyde, Ohio, Trump said the US is too dependent on foreign medicines and supplies. “As we’ve seen in this pandemic, the United States must pro...
  • Regulatory NewsRegulatory News

    Pandemic prompts mask, ventilator EUAs from FDA

    This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use surgical masks and provided updated information on “in-use time” for certain drugs used to treat patients with COVID-19, the novel coronavirus.   Ventilator-related EUAs The US Food and Drug Administration (FDA) on 4 August issued EUAs for three devices that relate to mechanical ventilation o...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom and Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan  and Australia.   Pot...
  • Regulatory NewsRegulatory News

    FDA updates bioresearch monitoring e-submission guide

    A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.   The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework la...