Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN Poll

Nov 02, 2011

Defining FDA-Regulated Nanotech

FDA recently issued a draft guidance on whether an FDA-regulated product involves nanotechnology, followed by a 60-day comment period. During this time stakeholders expressed general support but also made their case for less red tape and more leeway; all the details can be read here. One major concern related to the agency’s definition of a nanomaterial. FDA had stated that it would ask (1) whether engineered materials and their end products have at least one dimension ranging from 1 to 100 nm, and (2) whether they exhibit physical or chemical properties or biological effects attributable to its dimensions even if they fall outside the nanoscale range, but going up to a maximum of one micrometer. Do you think these details are clear enough?

Does FDA need to provide more clarity on its proposals regarding which FDA-regulated products involve the application of nanotech?


Related content


GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »