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.

While the rules and definitions for nanomedicines are still being developed, companies could find guidance in the rules for other medicines, Tyler said, warning that her comments were not representative of FDA policy.
Many biological products fall into the same size range as nanomedicines. While biologics aren’t nanotech drugs, they can share some of the stability and manufacturing issues that nanomedicines have. The FDA has a biologics guidance on stability — a compound’s shelf life and the reaction to environmental factors.
“I got in trouble when I called it a long guidance — it’s 80 pages long,” Tyner said. “I’m told it’s a comprehensive guidance.”
The absence of rules has not prevented companies from working on nanomedicines. Maryland nanomedicine company CytImmune Sciences developed a system for targeted delivery of chemotherapy to cancer tumors using gold nanoparticles. The technology requires lower quantities of the drug and patients should experience fewer side effects, said CEO & co-founder Larry Tamarkin.
But nanomedicine’s Achilles’ heel is manufacturing, Tamarkin said. Nanomedicine manufacturing is complex and the FDA will want to see manufacturing done to certain standards.
“If you can’t do that, it’s going to be a hard slog,” Tamarkin said.
CytImmune opted to endure the FDA’s case-by-case treatment, needing more than a decade “to go from bench to bedside.” The company’s lead candidate is still years from completing clinical trials, Tamarkin said.
While some companies may charge ahead in bids for FDA clearance, others might benefit from waiting for precedents to be established, said Nancy Teague, who spent 30 years in FDA life sciences and is currently executive director of regulatory affairs for Wilmington, N.C.-based Pharmaceutical Product Development Inc. (NSDQ:PPDI).