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  • 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...
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    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...
  • 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...
  • ReconRecon

    Recon: France, Italy and Belgium halt hydroxychloroquine use for COVID-19; Novavax buys Praha vaccines for $167M to boost capacity

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: Hydroxychloroquine not effective against coronavirus ( Politico ) Moderna execs have cashed out $89M in shares this year, as stock soared on vaccine hopes ( STAT ) Trump administration to take action to cap insulin costs for seniors ( Washington Post ) ( STAT ) ( NPR ) Quest Diagnostics launches coronavirus testing for employees returning to work ( Reut...
  • Regulatory NewsRegulatory News

    UK grants early access to remdesivir for COVID-19

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a positive early access to medicines scheme (EAMS) opinion for Gilead Sciences’ remdesivir to provide the drug via the National Health Service to certain hospitalized patients with severe cases of coronavirus disease (COVID-19).   “For the time being and due to limited supplies, treatment will be prioritised for patients who have the greatest likelihood of deriving the most benefit,” ...
  • ReconRecon

    Recon: Sanofi to sell $13B stake in Regeneron; Merck to buy vaccine maker Themis Bioscience

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to buy back $5 billion stake held by Sanofi ( Reuters ) ( Financial Times ) Merck to buy Austrian vaccine maker as it jumps into COVID-19 race ( Reuters ) ( STAT ) FDA shuffles longtime division head, Janet Woodcock, to focus exclusively on Covid-19 vaccine project ( STAT ) Evofem's gel first non-hormonal contraceptive to get approval in over 30 year...
  • Regulatory NewsRegulatory News

    FDA warns Seattle-based company for marketing COVID-19 vaccine

    The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) on Thursday warned Seattle-based firm North Coast Biologics for marketing an unapproved vaccine for SARS-CoV-2, the virus that causes COVID-19, on Facebook and LinkedIn in March and April.   The warning letter comes nearly a month after Washington Attorney General Bob Ferguson sent a cease and desist letter to North Coast Biologics President Johnny Stine ordering him to “immediately stop mak...
  • ReconRecon

    Recon: FDA approves Sunovion Parkinson’s drug; Oxford-AZ vaccine moving to Phase 2/3 trials

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A quarter of Americans are hesitant about a coronavirus vaccine - Reuters/Ipsos poll ( Reuters ) Drug touted by Trump as COVID-19 treatment tied to increased risk of death: study ( Reuters ) ( Washington Post ) ( STAT ) ( The Lancet ) Prominent Scientists Denounce End to Coronavirus Grant ( NYTimes ) ( Science ) 'This is a bad practice': Doctors question FDA p...
  • Regulatory NewsRegulatory News

    FDA issues guidance on PMA, HDE supplements amid COVID-19

    The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their devices without submitting a premarket approval (PMA) or humanitarian device exemption (HDE) supplement or a 30-day notice during the coronavirus disease (COVID-19) public health emergency.   FDA says the policy is meant to give device makers additional flexibility to address supply chain issues stemming ...
  • Regulatory NewsRegulatory News

    FDA names companies removed from antibody test list

    After tightening its oversight of antibody tests for coronavirus disease (COVID-19) earlier this month, the US Food and Drug Administration (FDA) on Thursday began publicly listing commercial manufacturers that have either failed to submit an emergency use authorization (EUA) request or voluntarily withdrew notification for their antibody tests distributed under the agency’s former policy.   In its initial policy in March, FDA said it would not object to the developmen...
  • ReconRecon

    Recon: US secures 300M doses of potential AZ-Oxford vaccine; Beximco launches generic remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US gives up to $1.2 billion to AstraZeneca for Covid-19 vaccine ( STAT ) ( Reuters ) ( FT ) Trump’s Vaccine Chief Has Vast Ties to Drug Industry, Posing Possible Conflicts ( NYTimes ) Biosimilars got the cold shoulder from health plans when it came to preferred coverage ( STAT ) GSK ties up with gene editing start-up Mammoth for COVID-19 test ( Reuters ) High...