- Traditionally, the process of adopting new FDA standards has been long and complex. But as RAPS' Alec Gaffney reports, since January 2014, the FDA has adopted three nanotech standards, underscoring a new regulatory arena and a new era of nanomedicine.
- Since 1998, the FDA has added 38 new standards to its list. However, the agency's adoption of nanotech-focused standards is different because of just how rapidly they're being adopted.
- Two of the new standards were developed by the American Society for Testing and Materials (ASTM) and one of the new standards was developed by the International Organization for Standardization.
According to the FDA, nanotechnology products are generally defined as materials between one nanometer (nm) and 100 nm (although some can be as big as 1000 nm).
In 2011, the FDA adopted preliminary guidance on nanotechnology, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, which was then finalized in June 2014. The guidance covered all nanotech products used in various pharmaceuticals, biologics, medical devices, or dietary supplements.
With three new standards in place, the FDA is still in the process of defining its regulatory approach to nanotechnology, but the signal is clear: Nanotechnology is an important part of innovative biopharmaceutical R&D and is here to stay.