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- FDA releases draft guidance to speed cell and gene therapy approvalsThe FDA announced a draft guidance aimed at helping developers bring gene therapies to patients more quickly. It encourages use of publicly available scientific data and existing platform knowledge…
- FDA releases draft guidance to trim animal testing in cancer drug developmentThe FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…