O QUE SIGNIFICA OFF LABEL EM INGLÊS
Uso fora do rótulo
O uso fora do rótulo é o uso de medicamentos para uma indicação não aprovada ou em uma faixa etária não aprovada, uma dosagem não aprovada ou uma forma de administração não aprovada. Tanto os medicamentos prescritos como os medicamentos de balcão (OTCs) podem ser usados em formas fora de rotulagem, embora a maioria dos estudos de uso fora do rótulo se centre em medicamentos prescritos. O uso fora do rótulo é geralmente legal, a menos que viole diretrizes éticas específicas ou regulamentos de segurança, mas traz riscos para a saúde e diferenças na responsabilidade legal. Um exemplo importante de como as agências reguladoras se aproximam do uso de rotulagem é fornecido pelo Centro de Avaliação e Pesquisa de Medicamentos e Alimentos e Medicamentos (FDA) dos Estados Unidos (FDA), que analisa o aplicativo de novas drogas (NDA) de uma empresa para dados de ensaios clínicos para ver Se os resultados suportam o medicamento para um uso ou indicação específica. Se estiver convencido de que o medicamento é seguro e eficaz, o fabricante da droga e a FDA concordam em linguagem específica que descreve a dosagem, via de administração e outras informações a serem incluídas no rótulo do medicamento. Mais detalhes estão incluídos no pacote da droga.
definição de off label no dicionário inglês
A definição de fora do rótulo no dicionário está relacionada ao uso, ou a ser usada, de maneiras para as quais não foi aprovada.
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10 LIVROS EM INGLÊS RELACIONADOS COM «OFF LABEL»
Descubra o uso de
off label na seguinte seleção bibliográfica. Livros relacionados com
off label e pequenos extratos deles para contextualizar o seu uso na 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 NOTÍCIAS NAS QUAIS SE INCLUI O TERMO «OFF LABEL»
Conheça de que se fala nos meios de comunicação nacionais e internacionais e como se utiliza o termo
off label no contexto das seguintes notícias.
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»