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

Facial plastic surgery clinics of North America 2007 Vol.15(2) p. 247-50, vii-viii

Reiter D

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【연구 목적】 안면 성형외과에서 식품의약국(FDA) 승인 외 용도(off-label use)의 약물 및 제품 사용이 널리 행해지고 있음을 인정하며, 이러한 관행이 법적 문제를 유발하지 않음을 명시한다.

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BibTeX ↓ RIS ↓
APA Reiter D (2007). Sailing the straits of approval: the nature of FDA approval and its implications for surgeons.. Facial plastic surgery clinics of North America, 15(2), 247-50, vii-viii. https://doi.org/10.1016/j.fsc.2007.01.009
MLA Reiter D. "Sailing the straits of approval: the nature of FDA approval and its implications for surgeons.." Facial plastic surgery clinics of North America, vol. 15, no. 2, 2007, pp. 247-50, vii-viii.
PMID 17544941
DOI 10.1016/j.fsc.2007.01.009

Abstract

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.

추출된 의학 개체 (NER)

유형영어 표현한국어 / 풀이UMLS CUI출처등장
약물 Administration-approved scispacy 1
약물 FDA scispacy 1

MeSH Terms

Drug Approval; Humans; Surgery, Plastic; United States; United States Food and Drug Administration

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