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

  • ReconRecon

    Recon: WHO launches COVID-19 IP pool with 30 countries; Sanofi vaccine chief heads to Ipsen

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Administration initially dispensed scarce covid-19 drug to some hospitals that didn’t need it ( Washington Post ) Additional blood cancer responses seen with Allogene’s off-the-shelf CAR-T cells, updated study shows ( STAT ) ( Endpoints ) US hospitals slash use of drug championed by Trump as coronavirus treatment ( Reuters ) US FDA approves Eli Lilly's diagnos...
  • Regulatory NewsRegulatory News

    EMA explains GMP and GDP flexibilities amid COVID-19

    The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).   (RELATED: EMA Q&A explains regulatory expectations for drugs during the...
  • Regulatory NewsRegulatory News

    Health Canada releases guidance to streamline COVID-19 clinical trials

    Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.   The IO has dropped administrative requirements for non-significant changes during a...
  • 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. To date, just two therapeutics are approved to treat COVID-19: Avigan (favilavir) in  China  and Italy, and Veklury (remdesivir) in  Japan . The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19 while the world waits for vaccine candidates to reach the market.   Potential ther...
  • Regulatory NewsRegulatory News

    FDA approves IV artesunate for severe malaria

    The US Food and Drug Administration (FDA) on Tuesday approved what is now the only treatment for severe malaria in the US following the marketing discontinuation of Eli Lilly’s quinidine in 2019.   The approval was granted to Amivas, LLC for its intravenous (IV) artesunate product, which was co-developed with the US Army under a cooperative research and development agreement (CRADA) that began in 2017 and led to the Army granting Amivas an exclusive license to a p...
  • Regulatory NewsRegulatory News

    FDA labeling study helps clear path for OTC naloxone

    Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   This tracker lists COVID-19 vaccine candidates currently in Phase 1-3 trials, as well as major candidates in pre-clinical stages o...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    The article discusses drug shortages in Germany the root causes of production problems with active pharmaceutical ingredients and drug product manufacturers. The authors offer analysis from a medium-sized generic drug manufacturer’s perspective. They offer a variety of reasons, all of which point to a “broken marketplace.” The article concludes with a discussion of mitigation activities and in an epilog address the current COVID-19 pandemic, warning that drugs and active i...
  • RoundupsRoundups

    EU Regulatory Roundup: MEB becomes a cornerstone of EMA assessments

    The Dutch Medicines Evaluation Board (MEB) has increased its share of European human rapporteur and co-rapporteur cases to become the dominant force in the centralized authorization procedure.   After Amsterdam was identified as the European Medicine Agency’s (EMA) next home, MEB began collaborating with regulators in other Member States to ensure work previously performed by the United Kingdom could be spread across multiple agencies. The initiative was intended to sp...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS unveils new 'Member Dashboard'

    RAPS has launched its brand new, online Member Dashboard , giving RAPS members one central place to view, access and manage their RAPS resources and member benefits. Once logged in, the dashboard displays your member profile and stored contact information, announcements, and key member resources, including webcasts, publications and other member-exclusive tools and content. As RAPS has continued to add to its menu of member benefits and other offerings, keeping track o...
  • ReconRecon

    Recon: FDA finds NDMA in some metformin products; EU plans permanent medical stockpile

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US “I’ll Send You the Contact”: Documents Expose FDA Commissioner’s Personal Interventions on Behalf of Trump’s Favorite Chloroquine Doctor ( Vanity Fair ) US coronavirus deaths top 100,000 as country reopens ( Reuters ) FDA Finds Carcinogen in Some Versions of Metformin ( Bloomberg ) ( Reuters ) ( STAT ) Pfizer ties up with glass maker Corning for vial supply ( ...
  • Regulatory NewsRegulatory News

    FDA explains impact of COVID-19 on applications, formal meetings

    The US Food and Drug Administration (FDA) on Tuesday issued immediately effective guidance explaining how the coronavirus disease (COVID-19) public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.   The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (P...