The committee makes recommendations regarding appropriate regulatory actions to be taken based on a scientific evaluation and risk assessment. The TIACC can take a number of actions:
- Remove inequivalent products from the market
- Evaluate and change the therapeutic equivalence rating of a product
- Recommend a grandfathered product submit a new drug application and require approved generics
- Test and evaluate the relationship of dissolution to bioequivalence
- Recommend appropriate dissolution specifications for narrow therapeutic drugs
- Evaluate the toxicity profile of injectables and mandate appropriate controls
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Topic: page 3 of 3 (Lesson: page 23 of 39)