Free Online Dictionary
|Wikipedia English The Free Encyclopedia||Download this dictionary|
Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.
|See more at Wikipedia.org...|
The following video provides you with the correct English pronunciation of the word "off-label", to help you become a better English speaker.
© This article uses material from Wikipedia® and is licensed under the GNU Free Documentation License and under the Creative Commons Attribution-ShareAlike License
|NCI Dictionary of Cancer Terms||Download this dictionary|
Describes the legal use of a prescription drug to treat a disease or condition for which the drug has not been approved by the US Food and Drug Administration.
A Service of the National Cancer Institute.
|The Glossary of the American Council on Science and Health||Download this dictionary|
To treat a condition that is not among the conditions for which the U.S. Food and Drug Administration approved the treatment.
|EN-ES Gonzalo||Download this dictionary|
expr.- uso extraoficial | uso para una indicación no recogida en la ficha técnica
s.- [Estud clin] empleo para indicaciones no autorizadas --Diorki--
| off-label in Spanish | off-label in German
You think you have ethics... Take the survey NOW!