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Home » FDA Issues Guidance on Nonclinical Safety Evaluation of Drug or Biologic Combinations
FDA Issues Guidance on Nonclinical Safety Evaluation of Drug or Biologic Combinations
March 15, 2006
Sponsors of products that combine two or more previously marketed drugs or biologics may be able to rely on existing clinical and nonclinical safety data before proceeding with clinical trials of the proposed combination therapy, according to a new FDA guidance.