RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    Coronavirus Relief Bill Includes OTC Drug User Fee Program

    A wide-ranging $2 trillion coronavirus emergency relief bill is expected to become law tomorrow and included in it are provisions not only related to drug and medical device shortages and COVID-19 testing, but also a new user fee system for over-the-counter (OTC) drugs. Overall, the bill is meant to provide relief to the struggling economy and to help government agencies and health facilities as more than 70,000 in the US now have COVID-19 and as the rate of new infecti...
  • ReconRecon

    Recon: FDA Approves BMS’ MS Drug, Launch Delayed by COVID-19; Pfizer Halts New Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves BMS MS drug, Covid-19 to delay launch ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Pfizer pauses new studies due to coronavirus pandemic ( Reuters ) Pfizer, Mylan say COVID-19 delays will postpone their Viatris merger ( Fierce ) ( Endpoints ) ( Press ) U.S. slashed CDC staff inside China prior to coronavirus outbreak ( Reuters ) HHS lists hydroxy...
  • Regulatory NewsRegulatory News

    EMA Offers Methodological Considerations for Trials During COVID-19 Pandemic

    The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline on points that clinical trial sponsors should consider on the implications of  the coronavirus disease (COVID-19) on methodological aspects of ongoing trials. While noting that “it is not possible to give general applicable advice on how the different aspects related to the pandemic should be handled, as implications on clinical trials are expected to be manifold,” the EMA’s...
  • Regulatory NewsRegulatory News

    FDA Eases Import Requirements for Devices and PPE to Fight Coronavirus

    To increase the availability of personal protective equipment (PPE) and other medical devices amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Tuesday eased import requirements for certain products.   Typically, companies importing FDA-regulated products are required to submit entry information to the agency for the products.   However, to ease burdens on importers and speed up the entry process for PPE and certain devi...
  • Regulatory NewsRegulatory News

    Gilead Asks FDA to Rescind Orphan Designation for COVID-19 Antiviral

    In a reversal, Gilead said Wednesday that it submitted a request to the US Food and Drug Administration (FDA) to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19. Earlier in March, Gilead was granted the designation because the potential antiviral would help to treat COVID-19, which currently affects fewer than 200,000 patients in the US. If the company had kept the designation and remdesivir w...
  • ReconRecon

    Recon: Congress, White House Reach Deal on $2T Stimulus; Merck KGaA’s MET Inhibitor Approved in Japan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Congress and White House Strike Deal for $2 Trillion Stimulus Package ( NYTimes ) ( Politico ) 5 Key Things in the $2 Trillion Coronavirus Stimulus Package ( NYTimes ) Oracle Providing White House With Software to Study Unproven Coronavirus Drugs ( NYTimes ) ( The Hill ) Trump seeks South Korea's help for medical equipment to tackle coronavirus ( Reuters ) Ma...
  • Regulatory NewsRegulatory News

    European Commission Seeks to Delay MDR by a Year

    As COVID-19 continues to disrupt Europe and pull medical device companies in different directions, Stella Kyriakides, European Commissioner for Health and Food Safety, said Wednesday that the commission will propose to delay the implementation of the Medical Devices Regulation (MDR) by one year. MDR was due to apply from 26 May.   If approved, the delay will come as a relief to device manufacturers. MedTech Europe on Monday called on the commission to pause the date ...
  • Regulatory NewsRegulatory News

    ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies

    After meeting last week to discuss vaccine development for the coronavirus disease (COVID-19), the International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday released guidelines for the data required before proceeding to first-in-human (FIH) studies for candidates.   So far, two vaccine candidates developed by Moderna and CanSino Biologics have moved into Phase I clinical testing, while many other companies and researchers have said they are in pr...
  • Regulatory NewsRegulatory News

    FDA: Flexible COVID-19 Testing Policy Doesn’t Apply to At-Home Tests

    After warning consumers against “unauthorized fraudulent” at-home test kits for detecting coronavirus disease (COVID-19) last Friday, the US Food and Drug Administration (FDA) has clarified that such tests would not qualify for its policy aimed at speeding the availability of laboratory-based tests.   Testing for COVID-19 in the US was initially hampered by a faulty early version of a test developed by the Centers for Disease Control and Prevention and the limited avai...
  • Regulatory NewsRegulatory News

    Convalescent Plasma: FDA Facilitating Emergency Access

    One potential treatment for COVID-19, known as convalescent plasma, may be derived from patients who have already recovered from the disease, and the US Food and Drug Administration (FDA) said Tuesday that it will help to provide access to it for patients with serious or immediately life-threatening COVID-19 infections. The idea behind the treatment is that plasma collected from patients recovering from COVID-19 may contain antibodies to the virus that might be effectiv...
  • RoundupsRoundups

    Asia Regulatory Roundup: India Opens Regulatory Fast Track to COVID-19 Drugs, Vaccines and Diagnostics

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Opens Regulatory Fast Track to COVID-19 Drugs, Vaccines and Diagnostics   The Central Drugs Standard Control Organization (CDSCO) of India has unveiled a series of actions designed to accelerate development of drugs, vaccines and diagnostics for use in the management of the COVID-19 pandemic.   Like many of its peers, CDSCO wants to work with developers of ...
  • ReconRecon

    Recon: Moderna Says COVID-19 Vaccine may Reach Health Care Workers by Fall; BMS Puts New Trials on Hold

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US has potential of becoming coronavirus epicenter, says WHO ( Reuters ) Trump and FEMA chief contradict each other on Defense Production Act ( CNN ) Trump will use Defense Production Act to secure thousands of test kits ( Politico ) Mnuchin hopes deal is 'very close' on $2-trillion coronavirus aid package in US Senate ( Reuters ) Pelosi: "Real optimism" for ...