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  • Regulatory NewsRegulatory News

    EMA Advises on Compassionate Use Programs for Remdesivir

    The European Medicines Agency (EMA) on Friday released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials.   EMA says it received requests from four EU member states, Estonia, Greece, the Netherlands and Romania, asking for advice on providing early access to the drug.   Initially developed as an antiviral therapy to t...
  • Regulatory NewsRegulatory News

    PDUFA, BsUFA Resource Capacity Planning: Report Recommends Refinements

    A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs.   Background   A workload adjustment mechanism was first introduced under PDUFA III, as “a means to adjust the annual PDUFA target revenue to account for long-term changes in the volume of certain regul...
  • Regulatory NewsRegulatory News

    3M Questions Trump Order to Halt Respirator Exports

    The Trump Administration on Thursday formally invoked the Defense Production Act (DPA) to require 3M to prioritize orders from the Federal Emergency Management Agency for N95 respirator masks and requested that the firm cease exporting respirators to Canada and Latin America. Trump tweeted late Thursday: “We hit 3M hard today after seeing what they were doing with their Masks. ‘P Act’ all the way. Big surprise to many in government as to what they were doing - will ...
  • RAPS' LatestRAPS' Latest

    FDA and China’s NMPA Expedite COVID-19 Emergency Approvals

    In just a short time, the COVID-19 pandemic has dramatically changed the way we live and work, strained healthcare systems, and caused companies and governments to prioritize fighting the coronavirus above virtually all else. Regulators like the US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have moved to fast-track the review of products that might be used to prevent or treat COVID-19. Regulators Speed Up Review Times ...
  • TrackersTrackers

    COVID-19 Therapeutics Tracker

    Welcome to the Regulatory Focus COVID-19 Therapeutics Tracker , your go-to resource for information on developing COVID-19 treatment candidates.   As COVID-19 continues to spread around the globe, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace.   In the US, funding is led by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH), while some companie...
  • Regulatory NewsRegulatory News

    European Commission Proposes to Delay MDR by a Year Due to COVID-19

    The European Commission on Friday released a proposal that would defer for a year the Medical Devices Regulation (MDR) from taking effect on 26 May. With an eye toward avoiding the disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. The delay also will “not impose new obligations on the concerned parties. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, ...
  • Regulatory NewsRegulatory News

    Priority Reviews for Class III Devices Increase Likelihood of Recalls, Study Finds

    A research letter published in JAMA Internal Medicine this week finds that class III medical devices that receive expedited reviews are more likely to be recalled, and after spending less time on the market, than devices that undergo a standard premarket approval (PMA) review.   Background   FDA has offered expedited reviews for promising new devices in various forms for decades. In 1989, the agency issued a general program memorandum detailing processes for expe...
  • ReconRecon

    Recon: Moderna Says Coronavirus Vaccine Phase II Studies Could Start This Spring; German Vaccine Makers Want Trial Rules Eased

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US No 'magic pill': The fight over unproven drugs for coronavirus ( Politico ) Trump invokes Defense Production Act for ventilator manufacturing ( CNBC ) ( MedtechDive ) Do social distancing better, White House doctor tells Americans. Trump objects ( Reuters ) Opioid supply crunch for US coronavirus patients prompts appeal to relax limits ( Reuters ) FDA Relaxes...
  • Regulatory NewsRegulatory News

    Why FDA’s Issuance of EUAs are Not ‘Approvals’ and Why That Matters

    You may have read that some drugs are now “approved” to treat COVID-19, or as the New York Times reported yesterday, that the US Food and Drug Administration (FDA)  “approved” the first serology test for COVID-19, or that the dozens of marketed COVID-19 diagnostics are “approved” by FDA. But in reality, FDA still has not approved any treatment or test for COVID-19 and has instead issued what are known as emergency use authorizations, or EUAs. From an outsider’s persp...
  • Regulatory NewsRegulatory News

    MHRA Details Wide-Ranging Flexibilities Amid COVID-19

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week outlined wide-ranging “regulatory flexibilities” to better facilitate the response to the coronavirus disease (COVID-19) pandemic.   The flexibilities extend to clinical trials, inspections, drugs and medical devices and include relaxed requirements and expedited services in areas to support the development of products for COVID-19 and to ensure the UK’s supply of other medical products durin...
  • RoundupsRoundups

    EU Regulatory Roundup: MHRA Relaxes GMP Rules on Drug Imports to Ease Pandemic Logistical Challenges

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Approves Adapted CPAP Device for COVID-19, Shares Design Specifications   The United Kingdom’s Medicines and Healthcare and products Regulatory Agency (MHRA) has approved an adapted Continuous Positive Airway Pressure (CPAP) device developed by organizations including the Mercedes Formula One team. MHRA also shared specifications for a rapidly manufactured CPAP...
  • ReconRecon

    Recon: Amgen Joins Hunt for Coronavirus Drug; Novartis Cancels $1B Sale of Sandoz to Aurobindo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Questions About Accuracy of Coronavirus Tests Sow Worry ( WSJ ) A Ventilator Stockpile, With One Hitch: Thousands Do Not Work ( NYTimes ) Trump says US will soon have more ventilators than it needs for virus victims ( Reuters ) FEMA Hadn't Ordered Ventilators. Manufacturers Forged Ahead Anyway ( NPR ) Pelosi forms House committee to oversee coronavirus respon...