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  • Regulatory NewsRegulatory News

    MHRA Details Wide-Ranging Flexibilities Amid COVID-19

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week outlined wide-ranging “regulatory flexibilities” to better facilitate the response to the coronavirus disease (COVID-19) pandemic.   The flexibilities extend to clinical trials, inspections, drugs and medical devices and include relaxed requirements and expedited services in areas to support the development of products for COVID-19 and to ensure the UK’s supply of other medical products durin...
  • RoundupsRoundups

    EU Regulatory Roundup: MHRA Relaxes GMP Rules on Drug Imports to Ease Pandemic Logistical Challenges

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Approves Adapted CPAP Device for COVID-19, Shares Design Specifications   The United Kingdom’s Medicines and Healthcare and products Regulatory Agency (MHRA) has approved an adapted Continuous Positive Airway Pressure (CPAP) device developed by organizations including the Mercedes Formula One team. MHRA also shared specifications for a rapidly manufactured CPAP...
  • ReconRecon

    Recon: Amgen Joins Hunt for Coronavirus Drug; Novartis Cancels $1B Sale of Sandoz to Aurobindo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Questions About Accuracy of Coronavirus Tests Sow Worry ( WSJ ) A Ventilator Stockpile, With One Hitch: Thousands Do Not Work ( NYTimes ) Trump says US will soon have more ventilators than it needs for virus victims ( Reuters ) FEMA Hadn't Ordered Ventilators. Manufacturers Forged Ahead Anyway ( NPR ) Pelosi forms House committee to oversee coronavirus respon...
  • Regulatory NewsRegulatory News

    FDA Issues First EUA for Coronavirus Serology Test

    In a move that could help the US better understand who has already had COVID-19, the US Food and Drug Administration (FDA) on Thursday provided the first Emergency Use Authorization (EUA) for a serology test to North Carolina-based Cellex Inc. The test can detect SARS-CoV-2 antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG) that are generated as part of the human immune response to the virus. Although FDA recommends that results from serology testing should n...
  • RAPS' LatestRAPS' Latest

    Hear From the Experts who Wrote the Book

    RAPS has introduced a new, comprehensive resource that promises to find a secure place on every regulatory professional’s bookshelf. Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition , spans 18 chapters with updates from more than 30 leading regulatory experts. Topics range from why it is no longer enough for today’s regulatory professional to just focus on regulatory guidance, to a primer on regulatory intelligence, to defining regulatory strategies...
  • Feature ArticlesFeature Articles

    Regulatory Operations, Ethics and the Global Landscape

    Feature articles throughout March covered a variety of topics by leading regulatory experts, including underlying root causes of serious and continuing noncompliance and how professionalism, integrity and ethics can enhance communication between regulatory and cross-functional teams. Other key topics included the progression of regulatory intelligence and strategy to foster the evolving landscape, how the role of regulatory operations professionals is evolving and understa...
  • Regulatory NewsRegulatory News

    FDA Reports Shortage of Sedation Drug Used for Putting COVID-19 Patients on Ventilators

    The US Food and Drug Administration (FDA) on Thursday updated its list of drugs in shortage to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation. The updated listings for five manufacturers note an increased demand for midazolam and may just be the beginning of what's to come for other sedation drugs too. Michael Ganio, senior director of pharmacy practice and quality at the...
  • Regulatory NewsRegulatory News

    CDRH Warns 5 Device Firms in US, China, Hungary, Thailand and Taiwan

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released five warning letters sent to medical device manufacturers around the globe due to various violations. The release comes as device warning letters plunged nearly 90% over five years and as CDRH only issued nine warning letters in all of 2019. US For Nevada-based Steiner Biotechnology, an investigator from FDA’s Office of Bioresearch Monitoring Operation...
  • Regulatory NewsRegulatory News

    ICH: MedDRA Updated With Supplemental Codes for Coronavirus

    The International Council for Harmonisation (ICH) on Wednesday announced that the Medical Dictionary for Regulatory Activities (MedDRA) is being updated with new supplemental terms and corresponding codes related to coronavirus disease (COVID-19).   “The coronavirus pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue,” ICH says, noting that more terms are in the process of being rev...
  • Regulatory NewsRegulatory News

    Clinical Trials During COVID-19: Updates From FDA, MHRA and TGA

    The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.   The update comes as other regulatory authorities offer updates on managing new or ongoing clinical trials during the outbreak and as pharma companies have begun to halt or alter ongoing trials. Both European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulator...
  • Regulatory NewsRegulatory News

    EMA Limits use of Malaria Drugs for COVID-19 as FDA Reports Shortages

    Two drugs primarily used to treat malaria, chloroquine and hydroxychloroquine, should not be used to treat coronavirus disease (COVID-19) outside of clinical trials or emergency use programs, the European Medicines Agency (EMA) said Wednesday.   The agency said there is currently no evidence for the drugs’ efficacy in treating COVID-19 and warns that both drugs can have serious side effects.   “They must not be used without a prescription and without supervision by...
  • ReconRecon

    Recon: US Strategic Stockpile Running Out of Protective Gear; Teva Prevails in Patent Dispute Against Eli Lilly

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House Projects 100,000 to 240,000 US Coronavirus Deaths ( WSJ ) Informal discussions begin on 9/11-style commission on coronavirus response ( NBC ) ( WSJ ) ( The Hill ) Rick Scott calls for congressional inquiry into WHO's coronavirus response ( Politico ) Pence task force freezes coronavirus aid amid backlash ( Politico ) Diabetes, lung and heart disea...