The FDA has released the guidance document “Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry.” It finalizes the draft guidance issued December 18, 2017 and provides those that utilize nanotechnology in the development of human drugs and biologics, with the agency’s current thinking on topics like manufacturing process and environmental impacts. It also includes recommendations for applicants and sponsors of submissions for these products. View the complete guidance and delve into the details of the following sections:
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- Risk-Based Framework: Potential Risk Factors for Products Containing Nanomaterials
- Quality Recommendations
- Nonclinical Studies for Drug Products
- Clinical Development
- Environmental Impact Considerations
Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry
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