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  • Regulatory NewsRegulatory News

    What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests

    As hospitals as well as state and commercial labs have now ramped up their testing for the novel coronavirus to almost 100,000 tests per day, many observers, including the US Food and Drug Administration (FDA) are looking back at the last two months wondering what took so long to get to this point. A front-page article in Sunday’s New York Times explained how the virus spread for weeks without any testing, with experts pointing to early problems with the CDC’s first...
  • Regulatory NewsRegulatory News

    FDA Eases Regulatory Requirements on Surgical Gowns, Gloves

    As the number of COVID-19 cases increase in the US and hospitals struggle with keeping their doctors and nurses protected, the Food and Drug Administration (FDA) on Monday released guidance explaining how it will relax certain regulatory requirements to increase the production and availability of certain personal protective equipment (PPE) such as gowns and gloves.  As early as late February, FDA began warning of PPE shortages, and hospitals in areas hit hard by the c...
  • Regulatory NewsRegulatory News

    FDA EUA Allows States to Receive Unapproved COVID-19 Treatments

    Opening the door to the wider use of unapproved but potential COVID-19 treatments, the US Food and Drug Administration (FDA) late Sunday issued an emergency use authorization (EUA) to allow the US Biomedical Advanced Research and Development Authority (BARDA) to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to doctors, who can decide whether to prescribe them to hospitalized teen and adult patients with COVID-19 when a clinical trial is n...
  • Regulatory NewsRegulatory News

    Notifying FDA of Drug Shortages During the Pandemic: FDA Offers Guidance

    With an eye on drug supply disruptions, the US Food and Drug Administration (FDA) on Friday published new guidance on how manufacturers should notify FDA of permanent halts or interruptions to manufacturing certain products that are likely to lead to a meaningful disruption in supply. An FDA spokesman told Focus that so far, only one firm is reporting a shortage of one human drug. FDA previously declined to name the firm or the drug, citing confidential commercial i...
  • Regulatory NewsRegulatory News

    EMA Signs Off on Conditional Authorization for Novartis Gene Therapy

    The European Medicines Agency’s Committee for Advanced Therapies on Friday announced that it has recommended a conditional authorization for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) as a treatment for babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease. EMA’s recommendation is based on the preliminary results of one completed clinical trial and three supporting studies in patients with SMA with differ...
  • Regulatory NewsRegulatory News

    FDA Warns Irish Company for Marketing Unapproved COVID-19 Treatments

    As there are still no approved treatments for COVID-19, the US Food and Drug Administration (FDA) this week warned Ireland-based Carahealth for offering unapproved herbal products and other products referred to as “Immune Tonic” on its website to mitigate, prevent, treat, diagnose or cure COVID-19. The warning letter, released publicly on Friday, follows the distribution of warning letters to seven companies for making fraudulent and unsupported claims about products,...
  • Regulatory NewsRegulatory News

    FDA Ends CSR Pilot, Plots New Approach for Disclosing Study Reports

    The US Food and Drug Administration (FDA) on Thursday officially ended a fledgling pilot program that was part of an effort to provide more transparency on the drug approval process. The agency said it’s working on a new approach to disclosing study reports. Last June, the agency was already pushing away from the clinical study report (CSR) pilot because of lackluster participation (FDA noted that  Janssen was the only sponsor  that agreed to participate) and said it wo...
  • Regulatory NewsRegulatory News

    European Commission Adopts Revised Standards to Speed Devices to Market

    As part of work to facilitate a faster and less expensive conformity assessment procedure for those marketing certain medical devices, the European Commission earlier this week adopted revised harmonized standards. The commission's implementing decisions relate to the medical devices, in vitro diagnostics and active implantable medical devices directives. The revised standards are meant to speed the production of medical face masks, gloves, containers for intravenous in...
  • 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...
  • 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

    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...
  • 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 ...