Open AccessRegulating Off-Label Drug Use — Rethinking the Role of the FDA
Author(s) -
Randall S. Stafford
Publication year - 2008
Publication title -
new england journal of medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 19.889
H-Index - 1030
eISSN - 1533-4406
pISSN - 0028-4793
DOI - 10.1056/nejmp0802107
Subject(s) - medicine , drug , off label use , drug labeling , drug approval , medline , pharmacology , intensive care medicine , law , political science
Off-label prescribing is legal and common, but it is often done in the absence of adequate supporting data. Dr. Randall Stafford writes that although there is a strong rationale for greater FDA involvement in off-label use, it is moving toward relinquishing control in its new draft guidelines.
Accelerating Research
Robert Robinson Avenue,
Oxford Science Park, Oxford
OX4 4GP, United Kingdom
Address
John Eccles HouseRobert Robinson Avenue,
Oxford Science Park, Oxford
OX4 4GP, United Kingdom