How Does the FDA Evaluate Nanotechnology Products?
The FDA employs a risk-based approach to evaluate nanotechnology products. This involves:
Characterizing the nanomaterials to understand their properties, behavior, and potential impact. Assessing the potential for toxicity and other adverse effects through preclinical and clinical studies. Reviewing the manufacturing processes to ensure consistent quality and safety. Monitoring post-market data to identify any long-term effects or emerging risks.
