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Product quality for nanomaterials: current U.S. experience and perspective.
Katherine M Tyner1, Peng Zou1, Xiaochuan Yang1
1CDER/OPQ/SRS, FDA, Silver Springs, MD, USA.
Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology
|February 3, 2015
Summary
Nanotechnology and nanomaterials are driving novel drug delivery systems, leading to more FDA applications. Unique nanomaterial properties require special scientific considerations for drug evaluation, informed by approved products.
Area of Science:
- Pharmaceutical Sciences
- Nanotechnology
- Regulatory Science
Background:
- Increasing development of nanotechnology-based drug delivery systems and targeted therapies.
- Growing number of Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) submissions to the FDA for nanomedicines.
- Nanomaterials possess unique physicochemical properties (size, surface area, polydispersity) necessitating specific evaluation approaches.
Purpose of the Study:
- To review scientific considerations for evaluating drug products containing nanomaterials.
- To discuss challenges and best practices based on FDA-approved nanomedicines.
- To provide insights for navigating regulatory pathways for nanomedicines.
Main Methods:
- Review of FDA guidelines and regulatory practices for drug evaluation.
- Analysis of scientific considerations for nanomaterial-based drug products.
- Case study approach using FDA-approved drug products containing nanomaterials.
Main Results:
- Unique properties of nanomaterials require tailored scientific evaluation beyond standard drug assessment.
- Specific considerations include characterization, manufacturing, and safety assessments.
- Experience with approved products offers practical guidance for regulatory submissions.
Conclusions:
- Rigorous regulatory standards apply to nanomedicines, but unique properties demand specific scientific considerations.
- Understanding these considerations is crucial for successful drug development and FDA approval.
- This review synthesizes knowledge to aid developers and regulators in evaluating nanomedicine products.
