In addition to FDA initiatives, the enhanced authorities regarding postmarket safety of drugs that were included in FDAAA affect much of what FDA does. Specifically, they give FDA the authority to require:
- Companies to make safety-related labeling changes.
- Postmarketing studies and clinical trials if a significant safety issue arises.
- Risk evaluation and mitigation strategies, which are risk management plans designed to ensure that the benefits of a drug outweigh its known risks.
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Topic: page 3 of 3 (Lesson: page 40 of 52)