Nano-Based Drugs and Medical Devices: FDA's Track Record
Volume 4, Issue 2
Cindy H. Strickland, Treon, Aguirre, Newman and Norris, P.A.
Several medical products reportedly comprised of nanomaterials have already been
approved by the FDA for prescription use in humans. To date, only one new
nanopharmaceutical has gone through the entire rigorous FDA pre-market approval process.
Six other drugs and three medical devices using nanomaterials have also been approved through
abbreviated review procedures. This article identifies the drugs and medical devices approved
to date, discusses the nature and extent of their FDA review, and makes a few observations about
the trends that appear to be emerging.
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