The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, COVID-19 EMA Pandemic Task Force, Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FDA, Heads of Medicines Agencies, National Institute for Health and Care Excellence, NIH, Therapeutic Goods Administration, U.S. Cyber Command, U.S. House and Senate, Wuhan Institute of Virology.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit.
The latest global regulatory news, changes and updates affecting biopharma, including: Drug Enforcement Administration, Department of Health and Human Services, FDA, International Coalition of Medicines Regulatory Authorities, EMA, European Commission, National Institute for Health and Care Excellence, NIH, Office for Human Research Protections, Pharmaceuticals and Medical Devices Agency, Therapeutic Goods Administration.
PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
The latest global regulatory news, changes and updates affecting biopharma, including: Biotechnology Innovation Organization, Central Drugs Laboratory, Drugs Controller General, EMA, FDA, Gilead Sciences, Health and Human Services, Medicines and Healthcare Products Regulatory Agency, National Institute for Health and Care Excellence, Pfizer Healthcare India, Pharmaceuticals and Medical Devices Agency.
The latest global regulatory news, changes and updates affecting biopharma, including: Association for Accessible Medicines, Department of Justice, EMA, FDA, Federal Trade Commission, International Coalition of Medicines Regulatory Authorities, SEC, White House, World Health Organization.
BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks.
The latest global regulatory news, changes and updates affecting biopharma, including: 340B Health, Department of Health and Human Services, FDA, Health Resources and Services Administration, Institute for Clinical and Economic Review, Medicines and Healthcare products Regulatory Agency.
RSS
