Wednesday, June 24, 2009

Why we never touch a study without FDA approval

Last week, the U.S. Attorney's office announced that medical device maker Norian Corporation is being charged in connection to unlawful clinical trials. In a nutshell, they were conducting clinical trials for a device that was not FDA approved, for surgeries involving treating spinal compression in the elderly. The device was actually putting people at risk, and they still went ahead with the trials.

This is why many devices cannot be rushed to market; we must follow strict FDA guidelines. We are conducting many clinical trials with FDA-regulated botulinum injections (Botox alternatives), fillers, and laser studies, such as with Invasix, Scar Revlite, and more. This is something we are mindful of at Sanctuary Plastic Surgery, SMAC, and Skin Laser Surgery Specialists.

Despite being widely available throughout the world, it took Dysport a long time to release in the U.S. due to FDA guidelines that simply have to be followed. A paperwork snafu pushed it back from the first half of 2008 to just becoming available now.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

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