CDER's Nanoctechnology Database
- Authors:
- Center:
-
Contributing OfficeCenter for Drug Evaluation and Research
Abstract
Drug products containing nanomaterials are held to the same standards for quality, safety, and efficacy as any drug product, along with the same rigorous assessment criteria. Interest in nanomedicine has continued to increase over the past few decades, and submissions containing engineered nanoparticles to the FDA have followed this trend. Physicochemical characterization of nanotechnology presents unique challenges, due to, in part, small feature sizes and large surface areas. There have been great efforts within CDER and the Office of Pharmaceutical Quality (OPQ) to address and understand these challenges, especially as generics are developed. To this end, the need for an efficient method of organization for relevant drug submissions has become more prevalent. Previous tracking efforts have relied largely on curation into an Excel workbook, which has grown from 350 products to nearly a thousand in 5 years. This project aims to create a relational database comprised of nanotechnology submissions. This database will be searchable and able to return the results of user-specified queries to assist in effective data retrieval and analysis. This database will help to facilitate and align assessment efforts across OPQ, as well as help to understand the product lifecycle of submissions containing nanomaterials.