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Sponsors who fail to meet certain Risk Evaluation and Mitigation Strategy (REMS) requirements won’t face FDA action during the COVID-19 outbreak, the agency announced. Read More
President Trump has invoked the Defense Production Act in response to the growing coronavirus pandemic, enabling the federal government to order private industry to manufacture emergency medical supplies. Read More
Manufacturers need to provide two-week updates on any supply issues during the COVID-19 emergency and going forward, the FDA said in a new straight-to-final guidance. Read More
Researchers are “running out of funding fast, which means new developments may never reach clinical trials and, ultimately, achieve regulatory approval,” Wellcome Trust said. Read More
The World Health Organization’s director-general has endorsed the voluntary sharing of patent rights and pooling of data to help develop COVID-19 drugs. Read More
The Indian government said Tuesday that it will lift its newly imposed export restriction on the anti-malaria drug hydroxychloroquine, a potential COVID-19 treatment. Read More
The European Medicines Agency yesterday announced a new system for reporting drug shortages and potential supply disruptions as the COVID-19 pandemic takes a toll on the stock of some critical medicines. Read More
President Trump has reached out to India’s Prime Minister Narendra Modi following India’s export freeze on the COVID-19 treatment hydroxychloroquine, calling for an exception to the country’s new restrictions. Read More
A coalition of more than 50 rheumatology and lupus organizations urged all 50 governors in a letter to ensure patient access to chloroquine and hydroxychloroquine, which are used to treat lupus and arthritis, as well as malaria and now COVID-19. Read More