Document Detail

Sailing the straits of approval: the nature of FDA approval and its implications for surgeons.
MedLine Citation:
PMID:  17544941     Owner:  NLM     Status:  MEDLINE    
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.
David Reiter
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Facial plastic surgery clinics of North America     Volume:  15     ISSN:  1064-7406     ISO Abbreviation:  Facial Plast Surg Clin North Am     Publication Date:  2007 May 
Date Detail:
Created Date:  2007-06-04     Completed Date:  2007-08-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9414907     Medline TA:  Facial Plast Surg Clin North Am     Country:  United States    
Other Details:
Languages:  eng     Pagination:  247-50, vii-viii     Citation Subset:  IM    
Department of Otolaryngology-Head & Neck Surgery, Jefferson Medical College, 925 Chestnut Street, 6th Floor, Philadelphia, PA 19107, USA.
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MeSH Terms
Drug Approval / legislation & jurisprudence*
Surgery, Plastic / ethics,  legislation & jurisprudence*,  methods*
United States
United States Food and Drug Administration / legislation & jurisprudence*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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