QUÉ SIGNIFICA OFF LABEL EN INGLÉS
Uso fuera de la etiqueta
El uso fuera de la etiqueta es el uso de fármacos para una indicación no aprobada o en un grupo de edad no aprobado, una dosis no aprobada o una forma de administración no aprobada. Tanto los medicamentos recetados como los medicamentos de venta libre (OTC) pueden utilizarse de manera no etiquetada, aunque la mayoría de los estudios sobre el uso fuera de la etiqueta se centran en medicamentos recetados. El uso fuera de etiqueta es generalmente legal a menos que infrinja las normas éticas específicas o las normas de seguridad, pero sí conlleva riesgos para la salud y diferencias en la responsabilidad legal. Un ejemplo destacado de cómo las agencias reguladoras se aproximan al uso fuera de la etiqueta es proporcionado por el Centro de Evaluación e Investigación de Drogas de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) Si los resultados respaldan el fármaco para un uso o indicación específicos. Si está convencido de que el medicamento es seguro y eficaz, el fabricante del fármaco y la FDA acuerdan un lenguaje específico que describa la dosis, la vía de administración y otra información que se incluirá en la etiqueta del fármaco. Se incluye más información en el prospecto del medicamento.
definición de off label en el diccionario inglés
La definición de off label en el diccionario está relacionada con el uso, o el uso, de formas para las que no se ha aprobado.
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10 LIBROS DEL INGLÉS RELACIONADOS CON «OFF LABEL»
Descubre el uso de
off label en la siguiente selección bibliográfica. Libros relacionados con
off label y pequeños extractos de los mismos para contextualizar su uso en la literatura.
1
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
2
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.
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. ...
4
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 ...
5
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 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.
7
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 ...
8
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
9
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
10
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 ...
6 NOTICIAS EN LAS QUE SE INCLUYE EL TÉRMINO «OFF LABEL»
Conoce de qué se habla en los medios de comunicación nacionales e internacionales y cómo se emplea el término
off label en el contexto de las siguientes noticias.
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»