Encysive Hits Another Snag With Thelin
FDA requests the company reformat information included in its response to a second “approvable” letter.
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England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
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The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
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Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.