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

 
  • 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

    Euro Roundup: MEPs seek more power for EMA to address shortages

    Members of the European Parliament (MEPs) have voted overwhelmingly to give the European Medicines Agency (EMA) “a broader mandate and increased resources” to address supply disruptions from shortages of medicines.   The text, which MEPs adopted by 663-23, with 10 abstentions, calls for the European Commission and EU member states to address drug shortages from multiple angles, some of which involve passing regulations and empowering EMA.   “In the long term, EMA s...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on clinical trials, drug development for EoE

    The US Food and Drug Administration (FDA) has finalized a guidance for industry on development of drugs and therapeutic biologics for treating eosinophilic esophagitis (EoE), a chronic, allergic inflammatory disease of the esophagus, for which there are currently no approved therapies.   The guidance addresses the agency’s thinking on clinical trials and development programs, focusing on trial population and design, efficacy and safety, as well as pediatric considera...
  • ReconRecon

    Recon: Trump says he may block FDA vaccine EUA guidance; Gilead to pay $97M to settle kickback claims

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Top adviser steps aside from FDA COVID-19 vaccine reviews over potential conflict ( Reuters ) Trump says he might reject stricter FDA vaccine guidelines ( Politico ) ( Reuters ) ( Endpoints ) Azar falls in line under Trump again. Experts say he's reinforcing a dark signal sent to the FDA ( Endpoints ) AstraZeneca still waiting for FDA go-ahead to resume US tri...
  • FDA launches digital health center of excellence

    A new digital health Center of Excellence within the US Food and Drug Administration (FDA) aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.   The DHCoE’s website details services offered, including examples of CDRH-specific, FDA-wide and external efforts to “translate digital advances into tools that benefit consumers.” The Center is housed within FDA’s Center for Devices and Radiological Health (...
  • 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

    FDA updates benzodiazepine boxed warning

        The US. Food and Drug Administration (FDA) is requiring that the boxed warning on benzodiazepines be updated to provide a uniform description of the risks associated with all medications in the class.   On 23 September 2020, FDA announced in a Drug Safety Communication that current prescribing information for benzodiazepines "does not provide adequate warnings about the serious risks and harms associated with these medicines, so they may be prescribed and used ...
  • 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

    FDA issues proposed rule clarifying stance on intended use

    After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. The new rule would also repeal and replace the unimplemented portions of the earlier final rule.   The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a propos...
  • ReconRecon

    Recon: UK to host COVID vaccine challenge trials; Roche, AC Immune Alzheimer’s drug flops in Phase 2 study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day ( Washington Post ) ( FT ) ( NYTimes ) ( Reuters ) CDC Advisory Panel to Delay Vote on Initial Covid-19 Vaccine Rollout ( WSJ ) US health agency sets October 16 deadline for states to submit vaccine plans ( Reuters ) J&J kicks off final stu...
  • Feature ArticlesFeature Articles

    Gene therapies – The regulatory road to individualized medicine

    This article discusses the evolving US regulatory landscape for gene therapies. The author explores the recent history and developmental paradigm shifts for gene therapy products and concludes with advice for abbreviated development and thoughts on policies that will create a sustainable gene therapy ecosystem. The author examines the paradigm shift of clinical trial and lifecycle management for gene therapies and considers the changes to the US regulatory framework that ...
  • Regulatory NewsRegulatory News

    Generic drugmakers get cannabidiol bioequivalence guidance from FDA

    Manufacturers who seek to produce generic versions of cannabidiol oral solution received guidance from the US Food and Drug Administration (FDA) on establishing bioequivalence with the reference listed drug.   The guidance follows the June 2018 approval of Epidiolex (cannabidiol) oral solution to treat seizures associated with two rare and serious types of childhood epilepsy. Epidiolex was also approved to treat a third seizure condition, tuberous sclerosis complex, in...