Nanomedicine offers the promise of new drugs with targeted delivery and fewer side effects, but the companies developing such medicines encounter a challenge: The U.S. Food and Drug Administration has no official definition of nanotechnology.
Much of the guidance that could help nanomedicine companies remains unwritten. All products containing nanomaterials go through the FDA’s traditional regulatory pathways for small molecule drugs.
Missing nanomedicine regulation was the topic of the latest NanoBio Executive Roundtable in at Research Triangle Park Foundation’s headquarters in Durham, N.C.