The nonapproved use of medications.
The need for new treatments for both established and recently described disorders has heightened awareness of the drug approval process. In particular, many ophthalmologists have questioned the ramifications of using approved drugs in nonapproved settings (such as apraclonidine) and the means of obtaining investigational drugs for patient use. The authors review the legal structures established to address these concerns and recommended approaches ophthalmologists can take to minimize their exposure to legal complications.
Lee
P P
PP
Wilmer Ophthalmological Institute, Johns Hopkins Hospital, Baltimore.
Yang
J C
JC
D002986:Clinical Trials as Topic; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D015507:Drugs, Investigational / Q000627:therapeutic use*; D005128:Eye Diseases / Q000188:drug therapy*; D006801:Humans; D007880:Legislation, Drug; D009885:Ophthalmology; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational