Commissioner of Food and Drugs – Food and Drug Administration
Stephen M. Hahn M.D.
Associate Commissioner for Regulatory Affairs – Office of Regulatory Affairs
Judith A. McMeekin Pharm.D.
The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.
Announcement about Ibuprofen and COVID-19 (Washington, DC. 18 March, 2020)
Regarding information that appeared in the media about the risk of using ibuprofen in COVID-19 infections, between March 15 and March 18, 2020 the World Health Organization (WHO) and some regulatory authorities such as the European Medicines Agency (EMA), National Health Services (NHS) in the United Kingdom, Spanish Agency of Medicines and Medical Devices (AEMPS) in Spain, and the Health Products Regulatory (HPRA) in Ireland have stated that there is currently no evidence to support an aggravation of COVID-19 infection with ibuprofen or other NSAIDs.
In short and pending new data, we believe the approach suggested by the UK NHS is appropriate. It addresses the lack of evidence regarding harmful effects of ibuprofen on covid-19 infections and does not advise to discontinue ongoing treatments with this medicine but, if treatment is initiated, prioritizes the use of paracetamol to treat symptoms of the infection.
European Medicine Agency (EMA) is aware of reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19).
There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.
Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).
Coronavirus disease (COVID-19) is a new strain that was discovered in 2019 and has not been previously identified in humans.
Murilo Freitas - 18:24, 11 de December de 20191,126
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The Pan American Health Organization invites you to celebrate Universal Health Day 2019, with the theme “Universal health: everyone, everywhere” – Compact on Primary Health Care for Universal Health 2030.
The PAHO Director, Carissa F. Etienne, and representatives from the academic field, NGOs, and U.S. authorities will participate of the event. Speakers will talk about achievements and new challenges to achieve Universal Health by 2030, with reference to the Compact 30.30.30: Primary Health Care for Universal Health.
Murilo Freitas - 14:18, 3 de December de 20191,460
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The International Pharmaceutical Regulators provide Training Manual on the Basic of Analytical Comparability of Biosimilar Monoclonal Antibodies (English, Spanish, Russian) at http://www.iprp.global/page/biosimilar-activities
Murilo Freitas - 16:17, 2 de December de 20194,919
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The National Regulatory Authority from Brazil, ANVISA, was elected for the last vacant position at the Management Committee of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH.
For more information in Portuguese, please click here.
