
FDA Publishes Oncology Drug Guidance
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
On Sept. 28, 2017, FDA published
Risks from biosimilar products, interchangeable products, radio-pharmaceuticals, cellular and gene therapy products, or cancer vaccines are not addressed in the guidance. It also does not discuss margins of safety by exposure or dose.
The FDA guidance complements International Council for Harmonization (ICH) guidance and provides examples of alternative assessments and additional recommendations not described in ICH guidelines.
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