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  • Regulatory NewsRegulatory News

    Compounding Drugs During the Pandemic: FDA Offers Policy Clarifications

    In response to “many emails from stakeholders,” the US Food and Drug Administration (FDA) late Monday clarified a few policies related to drug compounding, including one on the limit on the interstate distribution of compounded drug products for pharmacy compounders. Overall, FDA said its policies are meant to protect patients from unsafe, ineffective and poor-quality compounded drugs while preserving access for patients. In one of the updates, FDA clarifies that a ...
  • Regulatory NewsRegulatory News

    FDA Offers Expanded Use for ECMO, Cardiopulmonary Bypass and Ophthalmic Devices Amid COVID-19

    The US Food and Drug Administration (FDA) on Monday issued guidance allowing for limited expanded use of extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices during the coronavirus disease (COVID-19) pandemic.   The agency also opened the door to expanded use for a range of ophthalmic assessment and monitoring devices to reduce the need for in-person visits to health care facilities during the outbreak.   ECMO and Cardiopulmonary Bypass Devi...
  • Regulatory NewsRegulatory News

    IMDRF Consultations Focus on IVD Classifications, Regulatory Assessors

    The International Medical Device Regulators Forum (IMDRF) recently released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators appropriately conduc assessments of Conformity Assessment Bodies (CABs). The 16-page proposed document on IVD classification is meant to help IVD manufacturers select an appropriate risk class using a set of harmonized classification principles and based on the device’s...
  • ReconRecon

    Recon: WHO, WIPO Eye Patent Workarounds Amid COVID-19; Trump Admin Orders 167M Respirators from 3M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US House Democrats to hold conference call with Pence, Fauci, Birx on coronavirus response ( CNBC ) Trade Adviser Warned White House in January of Risks of a Pandemic ( NYTimes ) ( Axios ) Trump attacks HHS watchdog ( Politico ) ( TPM ) Trump says he, others will be tested regularly ( Reuters ) Trump speaks with pharma, biotech CEOs about coronavirus therapies (...
  • RoundupsRoundups

    Asia Regulatory Roundup: NMPA Seeks to Ensure Quality of Exports as China Becomes Key Supplier of COVID-19 Devices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   NMPA Seeks to Ensure Quality of Exports as China Becomes Key Supplier of COVID-19 Devices   China is stepping up efforts to ensure the safety and quality of exported medical devices. The actions come as countries around the world look to China for equipment for use in the detection, prevention and treatment of the pandemic coronavirus.   With the SARS-CoV-2 outbr...
  • Feature ArticlesFeature Articles

    OTC Monograph Reform is Now Law: What’s Next?

    This article discusses the impact of over-the-counter (OTC) monograph reform, part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act . Regulators and public health stakeholders have been championing OTC monograph reform for more than five years. Then, in what seems like a blink of any eye, it is now law, passed by Congress and signed by the President on 27 March 2020 as part of the CARES Act for pandemic relief. The new law reflects the...
  • Regulatory NewsRegulatory News

    New System to Speed Industry-EMA Interactions on Drug Shortages

    The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday. Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceu...
  • Regulatory NewsRegulatory News

    FDA Relaxes Rules for Infusion Pumps, Clinical Thermometers

    Adding to a growing list of medical devices with eased regulatory requirements amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) over the weekend released new guidances for infusion pumps and clinical thermometers in an effort to increase availability of the devices.   The two guidelines, which take effect immediately, follow similar guidelines released in recent weeks covering diagnostic tests , ventilators , surgical appar...
  • Regulatory NewsRegulatory News

    FDA Drug Review Times Reflective of 4 Key Features, GAO Finds

    The length of review of new drug applications (NDAs) by the US Food and Drug Administration’s (FDA) divisions is generally contingent on four features of the application, according to the Government Accountability Office’s (GAO) analysis of 637 original NDAs submitted from fiscal years 2014 through 2018. Overall, GAO found that the four key features are: 1. Whether the NDA qualifies for a priority review, which is four months less than for an otherwise standard, 10-m...
  • ReconRecon

    Recon: GSK Partners With Vir for COVID-19 Treatments; Gilead to Donate 1.5M Doses of Remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US faces 'really bad' week as coronavirus deaths spike ( Reuters ) ( NBC ) Inside the epic White House fight over hydroxychloroquine ( Axios ) ( Reuters ) Pressed by Trump, US pushed unproven coronavirus treatment guidance ( Reuters ) ( NYTimes ) ( The Guardian ) ( WSJ ) Trump says thousands of military to be sent to help states battle coronavirus ( Reuters ) ...
  • Regulatory NewsRegulatory News

    Hospitals Report ‘Severe Shortages’ of COVID-19 Tests, HHS Survey Finds

    The US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) on Monday released the results of telephone survey of 323 hospitals across 46 states, the District of Columbia and Puerto Rico, finding “severe shortages of testing supplies and extended waits for test results.”    Hospitals reported that they were unable to keep up with COVID-19 testing demands because they lacked complete kits and/or the individual components and supplies needed t...
  • Regulatory NewsRegulatory News

    EMA Advises on Compassionate Use Programs for Remdesivir

    The European Medicines Agency (EMA) on Friday released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials.   EMA says it received requests from four EU member states, Estonia, Greece, the Netherlands and Romania, asking for advice on providing early access to the drug.   Initially developed as an antiviral therapy to t...