Meaning of "off label" in the English dictionary

PRONUNCIATION OF OFF LABEL

off label

GRAMMATICAL CATEGORY OF OFF LABEL

Off label can act as an adjective and an adverb.

The adjective is the word that accompanies the noun to determine or qualify it.

The adverb is an invariable part of the sentence that can change, explain or simplify a verb or another adverb.

WHAT DOES OFF LABEL MEAN IN ENGLISH?

Off-label use

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most study of off-label use centers on prescription drugs. Off-label use is generally legal unless it violates specific ethical guidelines or safety regulations, but it does carry health risks and differences in legal liability. A leading example of how regulatory agencies approach off-label use is provided by the United States Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research, which reviews a company's New Drug Application (NDA) for clinical trial data 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.

Definition of off label in the English dictionary

The definition of off label in the dictionary is relating to use, or being used, in ways for which it has not been approved.

TRANSLATION OF OFF LABEL

Find out the translation of off label to 25 languages with our English multilingual translator.

The translations of off label from English to other languages presented in this section have been obtained through automatic statistical translation; where the essential translation unit is the word «off label» in English.

• Translator English - Chinese: 关闭标签
• Translator English - Spanish: fuera de la etiqueta
• English: off label
• Translator English - Hindi: लेबल बंद
• Translator English - Arabic: خارج التسمية
• Translator English - Russian: от метки
• Translator English - Portuguese: off label
• Translator English - Bengali: লেবেল বন্ধ
• Translator English - French: hors AMM
• Translator English - Malay: Off label
• Translator English - German: off-Label-
• Translator English - Japanese: ラベルオフ
• Translator English - Korean: 라벨 해제
• Translator English - Javanese: Mati label
• Translator English - Vietnamese: tắt nhãn
• Translator English - Tamil: ஆஃப் லேபிள்
• Translator English - Marathi: ऑफ लेबल
• Translator English - Turkish: etiket kapalı
• Translator English - Italian: off label
• Translator English - Polish: off label
• Translator English - Ukrainian: від мітки
• Translator English - Romanian: de pe eticheta
• Translator English - Greek: off ετικέτα
• Translator English - Afrikaans: af etiket
• Translator English - Swedish: off label
• Translator English - Norwegian: off label

10 ENGLISH BOOKS RELATING TO «OFF LABEL»

Discover the use of off label in the following bibliographical selection. Books relating to off label and brief extracts from same to provide context of its use in English literature.

The Guide to Off-Label Prescription Drugs: New Uses for ...

"The Guide to Off-Label Prescription Drugs" provides you with the latest information on more than 1,500 breakthrough uses for prescription drugs.

Kevin R. Loughlin, Joyce Generali, 2006

Prescription Drugs: FDA's Oversight of the Promotion of ...

The FDA regulates the promotion of prescription drugs (PD) to ensure that promotional materials are not false and misleading and that they comply with applicable laws and regulations.

Marcia Crosse, 2008

Men's Health

And so on. These kinds of off-label uses are so common they're routine. Exact figures are difficult to pin down, but most sources estimate that one in four prescriptions in the United States is written for an off-label purpose. With total annual U.S. ...

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Drug Injury: Liability, Analysis, and Prevention

“Off-label use” refers to the practice of prescribing a manufactured drug for purposes other than those indicated on the product's federally mandated labeling . Off-label use of pharmaceuticals by physicians raises additional issues in the area of ...

Gopi Doctor Ahuja, 2005

Innovation in Medical Technology: Ethical Issues and Challenges

This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits. -- Jacob William Shatzer

Margaret L. Eaton, Donald Kennedy, 2009

Off-label Drug Facts

Off-Label Drug Facts is easy to use, with an efficacy rating system and indexes for generic and trade names, as well as therapeutic uses. Updates will include 510 new monographs with new agents profiled, revisions, and hot news items.

Dennis J. Cada, 2001

Medicare Prescription Drug Coverage For Dummies

When a doctor prescribes a drug off label, she's using that drug to treat a medical condition for which it hasn't received official approval. The U.S. Food and Drug Administration (FDA) approves drugs and allows them into the market to treat ...

Patricia Barry, 2008

Contrast Media: Safety Issues and ESUR Guidelines

June M.Raine CONTENTS 3.1 Introduction 15 3.2 Definition of a Medicine 15 3.3 The European Regulatory System 16 3.4 Definition of Off-Label Use 16 3.5 Special Populations and Special Therapeutic Areas 17 3.6 Legal Position of the ...

Henrik S. Thomsen, Judith A. W. Webb, 2009

Drug Therapy in Nursing

Because drugs in development were not tested on children, they were not labeled as approved for use in children. As a result, pediatricians must often prescribe medications for off-label uses in children. An off-label use is when a drug is used ...

Diane S. Aschenbrenner, Samantha J. Venable, 2009

The Price of Perfection: Individualism and Society in the ...

One study found that more than 20 percent of all prescriptions written by doctors in their offices were for unapproved uses, with the percentage of off-label prescribing for cardiovascular ailments as high as 46 percent.57 The study also found ...

Maxwell J. Mehlman, 2009

6 NEWS ITEMS WHICH INCLUDE THE TERM «OFF LABEL»

Find out what the national and international press are talking about and how the term off label is used in the context of the following news items.

FDA approves Sanofi/Regeneron cholesterol drug with limits

Physicians can prescribe drugs "off label" to any patient even if the FDA has not approved it for that patient group, but insurance companies ... «Reuters, Jul 15»

New online GST could affect gay men currently importing PrEP

Men who have sex with men will be interviewed as part of the Off Label study, where they will be asked about their experiences importing and ... «Star Observer, Jul 15»

Anacor Pharmaceuticals Raised to Buy at Goldman Sachs (ANAC)

The doctors also believe off label use could be significant in other types of dermatitis.”Nachman mentioned that the market model had been ... «WKRB News, Jul 15»

Leukemia Therapeutic Market – Global Industry Size, Trends …

Off label prescribing would support the growth of the global leukemia therapeutics market. In addition, limited number of market players would ... «Medgadget.com, Jul 15»

Did The DOJ Embrace The 2nd Circuit's Caronia Ruling In Amarin's …

It presents not only a stark philosophical divide as to the value of off label scientific and medical information, but also goes to the heart of the ... «Forbes, Jul 15»

Football - McGregor keen to shake off label

Football - McGregor keen to shake off label. Darren McGregor insists Rangers' support are right to label the remaining members of last ... «Yahoo Eurosport UK, Jun 15»