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

  • Regulatory NewsRegulatory News

    New FDA Program to Accelerate Coronavirus Treatments

    The US Food and Drug Administration (FDA) on Tuesday detailed a new “special emergency program” for accelerating research and development of potential treatments for coronavirus disease (COVID-19).   Details about the program come as the US faces the world’s largest COVID-19 outbreak, with Johns Hopkins University reporting more than 180,000 confirmed cases and 3,600 deaths attributed to the virus.   Under the coronavirus treatment acceleration program (CTAP), FDA ...
  • Regulatory NewsRegulatory News

    FDA Closes Zolgensma Data Manipulation Case Without Any Regulatory Action

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research on Tuesday said it has completed its review of Novartis’s data manipulation linked to its spinal muscular atrophy gene therapy Zolgensma (onasemnogene abeparvovec-xioi) and will not take regulatory action. Paul Richards, acting chief of CBER’s consumer affairs branch, told Focus : “FDA has completed its review of the inspection, the evidence collected, and the firm’s responses and ...
  • Regulatory NewsRegulatory News

    MHRA Blocks 135 Drugs From Parallel Export

    As drug shortage questions and increasing demands loom amid the coronvirus pandemic, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this month added 135 medicines to its list of medicines that cannot be parallel exported from the UK. Parallel exporting means buying medicines already on the market in the UK and selling them in another country in the European Economic Area. Beginning on 13 March, MHRA added hydroxychloroquine, a possible COVID-19 t...
  • RAPS' LatestRAPS' Latest

    Career Pathways in Regulatory Affairs

    This “how-to” article discusses career pathways in regulatory affairs. The author traces her career path as she grew from an administrative assistant to regulatory generalist to vice president and explores the critical skills she mastered along the way. The author covers necessary skill sets, the benefits of having a good mentor and the importance of taking chances, even at the risk of some failures.   Introduction   If, in 1999, when I was working as an administra...
  • ReconRecon

    Recon: China to Begin Reporting Asymptomatic Coronavirus Cases; Amarin Loses Vascepa Patent Suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump says coronavirus guidelines may get tougher; one million Americans tested ( Reuters ) Restrictions Are Slowing Coronavirus Infections, New Data Suggest ( NYTimes ) Top US expert sees 'glimmers' social distancing dampening virus spread ( Reuters ) US coronavirus death toll rises past 3,000 on deadliest day ( Reuters ) US Congress eyes next steps in coron...
  • Regulatory NewsRegulatory News

    FDA Warns Pfizer Manufacturing Site in India

    Following an inspection last August and September, the US Food and Drug Administration (FDA) sent a warning letter to Pfizer’s injectable product manufacturing site in Visakhapatnam, India. The letter, dated 25 March and released Tuesday, explains how the site did not adequately investigate root causes and implement corrective and preventive action (CAPA) to address deficiencies with its sterility testing. FDA also notes microbial contamination and how the site “did ...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Shares Guidance on Mitigating Ventilator Shortages During COVID-19 Pandemic

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Shares Guidance on Mitigating Ventilator Shortages During COVID-19 Pandemic   Australia’s Therapeutic Goods Administration (TGA) has shared details of how clinicians can mitigate shortages of ventilators triggered by surging numbers of COVID-19 cases. The agency proposes the modification of devices such as anaesthesia gas machines and production of ventilators ba...
  • TrackersTrackers

    COVID-19 Therapeutics Tracker

    Welcome to the Regulatory Focus COVID-19 Therapeutics Tracker , your go-to resource for information on developing COVID-19 treatment candidates.   As COVID-19 continues to spread around the globe, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace.   In the US, funding is led by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH), while some companie...
  • Regulatory NewsRegulatory News

    FDA Issues and Expands EUA for Respirator Decontamination System

    In a weekend turnaround, the US Food and Drug Administration (FDA) on Saturday gave emergency approval to the first system for decontaminating respirators to extend their use amid the coronavirus disease (COVID-19) pandemic, before expanding the terms of the authorization on Sunday.   The emergency use authorization (EUA) initially limited the number of respirators that could be decontaminated using the system to 10,000 per day, despite Battelle Memorial Institute’s ’s...
  • 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...
  • ReconRecon

    Recon: FDA Approves AZ’s Imfinzi for Untreated Small-Cell Lung Cancer; Merck, Bayer Drug Shows Promise in Heart Failure

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump backs off plan to reopen businesses by mid-April amid coronavirus warnings ( Reuters ) US health experts pushed strongly for Trump to extend coronavirus restrictions: Fauci ( Reuters ) Dr. Birx predicts up to 200,000 US coronavirus deaths 'if we do things almost perfectly' ( NBC ) Lawmakers’ coronavirus response means delays for drug pricing legislation ...
  • 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...