Entries from HEALTH LAW SECTION BLOG tagged with 'CBER'

Human Blood and Transfusion-screening tests

December 2010, FDA has issued its final guidance for the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and human cells/tissues/products thereof . Excerpted from the Guidance-These tests are intended...

Human Clinical Trials,Marketing Authorization for Pharmaceuticals-ICH

From FDA/CBER, Sept 4, 2008, a follow up on an ICH Harmonised Tripartite Guideline document, 'Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals' (M3(R2) Current Step 2 version dated 15 July...

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