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Jun 16, 2020 The U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19…
May 21, 2020 Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring.…
May 5, 2020 Manufacturing Quality Branch (MQB), Therapeutic Goods Administration (TGA), Australia has notified that they are intending to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) issued, 1 July 2018, as…
May 1, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has extended the validity of WHO GMP/ Certificate of Pharmaceutical Product (COPP) expiring from March 2020 to August 2020 by six months from…
April 30, 2020 Glenmark Pharmaceuticals announced that it has received the Drugs Controller General (I) permission to conduct clinical trial on Favipiravir. As on date, Glenmark is the first pharmaceutical company in India to be given an approval by…