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

 
  • Regulatory NewsRegulatory News

    Experts call on Hahn to shield FDA from political influence

    More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect the agency from political interference.   The letter comes days after President Donald Trump, who has repeatedly claimed that a coronavirus disease (COVID-19) vaccine could be authorized before the November election and accused FDA staff of being part of “the deep state,” said ...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been 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.   Convalescent plasma may be used in the US to treat hospitalized patients under an emergency use authorization (EUA) or an investigational new drug application (IND). “Adequate and well-controlled randomized trials remain ne...
  • 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.   To date, just one coronavirus vaccine has been  approved . Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamale...
  • Regulatory NewsRegulatory News

    Hahn pledges no politics in COVID vaccine decisions

    Testifying before the Senate Health, Education, Labor and Pensions Committee on Wednesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that politics will not play a part in the decision to approve or authorize a vaccine for coronavirus disease (COVID-19).   Hahn stressed that he supports science and has “100% confidence” in his staff, and said that, “FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous ...
  • Regulatory NewsRegulatory News

    GAO highlights continued PPE shortages in COVID-19 report

    The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of the US, according to new findings from the US Government Accountability Office (GAO).   In a wide-ranging report on the US federal response to COVID-19, the GAO issued 16 new recommendations for federal agencies spanning the medical supply chain, vaccines and therapeutics, COVI...
  • Regulatory NewsRegulatory News

    COVID-19 vaccine: Experts warn of waning public confidence

    Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine .   Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposi...
  • Regulatory NewsRegulatory News

    Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

    Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA).    The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical pro...
  • WHO: Two-thirds of global population now participating in COVAX initiative

    Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator. In all, 64 higher income countries have joined the COVAX facility, with an additional 38 expected to join soon. The United States, Russia and China are not among the countries joining the multinational effort.   World Health Organization (WHO) director-general Tedros Ghebreyesus led a 21 Sep...
  • Regulatory NewsRegulatory News

    EMA backs dexamethasone for COVID-19, seven new medicines and consults on ICH Q3D guideline

    The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q3D(R2) guideline on elemental impurities.   EMA also endorsed the use of dexamethasone to treat coronavirus disease (COVID-19) patients who are on oxygen or mechanical ventilation based on results from the RECOVERY trial.   “Published data from the RECOVERY study show that, in...
  • Regulatory NewsRegulatory News

    At Convergence, CDRH details its pandemic response

    As the coronavirus pandemic swept through major US cities in the spring of 2020, the US Food and Drug Administration took unprecedented steps to address shortages and bring tests and potential therapies online with alacrity.   One center at FDA, the Center for Diagnostic and Radiological Health (CDRH), was faced with deciding how to address the potential for dire shortages of medical devices, while considering how to address such unconventional solutions as 3D printing...
  • Regulatory NewsRegulatory News

    EMA to require clinical data publication for COVID-19 related products

    The European Medicines Agency (EMA) this week announced it will require drugmakers to publish clinical data for medicines and vaccines authorized to treat or prevent coronavirus disease (COVID-19) as part of its exceptional transparency measures during the pandemic.   After spending years implanting its policy for proactively publishing clinical data for products submitted to the agency for review, EMA suspended the publication requirement in August 2018 to focus on ...
  • Regulatory NewsRegulatory News

    FDA shares comparative performance data for COVID-19 tests

    The US Food and Drug Administration (FDA) on Tuesday released comparative performance data for 58 coronavirus disease (COVID-19) molecular diagnostics being used under emergency use authorizations (EUAs).   Specifically, FDA has published limit of detection (LoD) data for the tests against a standardized panel it developed and began distributing to test developers in May. FDA says it has so far contacted the developers of 176 authorized tests and has provided reference...