Guidance for Industry on Nonclinical Safety Evaluation of Drug or Biologic Combinations; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nonclinical Safety Evaluation of Drug or Biologic Combinations." This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), co-packaged products, and some adjunctive therapies.