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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is relaxing some GMP requirements to help manufacturers overcome challenges during the COVID-19 pandemic. Read More
In an emergency final guidance released yesterday, the FDA agency said it is temporarily relaxing its regulations for repackaging and combining units of propofol during the COVID-19 pandemic. Read More
The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable. Read More
Rick Bright, the ex-director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), said yesterday that he was removed from his post because he pushed back against the administration’s promotion of two anti-malaria drugs to treat COVID-19. Read More
A federal appeals court has ruled that Banner Life Sciences may make and market its version of Biogen’s blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate). Read More
The director of HHS’ Biomedical Advanced Research and Development Authority (BARDA), Rick Bright, has departed from the federal vaccine development agency to helm a new initiative on COVID-19 diagnostics at the National Institutes of Health (NIH). Read More
The United Nations adopted a resolution calling for pharma companies to waive exclusive rights for their vaccines and treatments during the COVID-19 crisis. Read More
The European Medicines Agency (EMA) recommended that good manufacturing practice (GMP) certificates for drugmakers be extended until the end of 2021 to avoid potential drug supply-chain disruptions during the pandemic. Read More