Systems Biology Opens New Research Pathways
Systems Biologists Are Attacking the Encrypted Messages That Would Allow Us to Predict and Change the Course of Disease
Individual Tumor Profiling
Has Tumor Molecular Profiling Enabled More Effective and Less Toxic Cancer Treatment?
Top 10 Under 40
Up-and-Coming Stars Shine in Biopharma Research and Business
Podcast: FDA’s New Commissioner Hits the Ground Running
Scott Gottlieb, M.D., Commits to Speeding Up Drug Reviews, and Maintaining Safety and Efficacy
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FDA recently issued a draft guidance on whether an FDA-regulated product involves nanotechnology, followed by a 60-day comment period.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?