The public docket on FDA’s reconsideration of the approval of Avastin for breast cancer has only gathered a few dozen responses. Those submissions overwhelming favor retaining the indication, but also raise some broader questions about the standards for accelerated approval in oncology.
By Laura Helbling
The size and scope of public comments made to the Food & Drug Administration regarding the accelerated approval status of Roche/Genentech's Avastin for breast
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
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.
