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1546-2080 Online :: 1546-203X Print
Nano-Based Drugs and Medical Devices: FDA's Track Record
Volume 4, Issue 2


Authors:
Cindy H. Strickland, Treon, Aguirre, Newman and Norris, P.A.

Abstract:
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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