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.
LONDON – The World Health Organization (WHO) has officially declared COVID-19 a pandemic, but is pushing back strongly against countries giving up on stringent control measures.
HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.
PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.
HONG KONG – Cadila Healthcare Ltd. (Zydus Cadila) has won approval for its saroglitazar to be used as the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH) in India. The green light from the Drug Controller General of India (DCGI) makes saroglitazar the first drug in the world approved for this indication.
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