Cosmetic Surgery Research Today is a free monthly online journal that collates and summarizes the latest research about Cosmetic Surgery, including details on microsurgery, reconstruction, techniques, risks.

Sailing the straits of approval: the nature of FDA approval and its implications for surgeons.

Reiter D

Department of Otolaryngology-Head & Neck Surgery, Jefferson Medical College, 925 Chestnut Street, 6th Floor, Philadelphia, PA 19107, USA. david.reiter@jefferson.edu

Use of Food and Drug Administration-approved medications and products for other than the approved indications is common in facial plastic surgery and violates no laws. Addressing practical concerns about such use strengthens the doctor-patient relationship and can minimize the risk of successful allegations of negligence in the event of untoward outcomes. The facial plastic surgeon can find support and assistance with off-label use in two general areas. Abundant scientific literature focuses on off-label use and addresses its practical, scientific, legal, moral, and ethical issues. The Food and Drug Administration also addresses off-label use in its own publications. It offers guidelines for physicians that, if followed, facilitate incorporation of off-label use into practice with minimal risk and maximum potential for therapeutic success.

Published 4 June 2007 in Facial Plast Surg Clin North Am, 15(2): 247-50, vii-viii.
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