CDER Tracking Drug Product Nanotechnology Use

Six CDER staffers say the Center is tracking the use of nanotechnology in drug products by building and interrogating a technical profile of products containing nanomaterials submitted to CDER. Writing online in Nature Nanotechnology (subscription or purchase required), the six say that data from more than 350 products show an increase in the submissions of drug products containing nanomaterials over the last two decades.

Of those submissions, they write, 65% are INDs, 17% are NDAs, and 18% are ANDAs, with the largest class of products being liposomal formulations intended for cancer treatments. Some 80% of the products have average particle sizes of 300 nm or lower.

“This analysis identifies several trends in the development of drug products containing nanomaterials, including the relative rate of approvals of these products, and provides a comprehensive overview on the landscape of nanotechnology application in medicine,” the authors say.