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Anvisa abre debate sobre novas regras para fitoterápicos
A diretoria da Anvisa aprovou, nesta quinta-feira (07/03), a iniciativa regulatória para revisão das normas de medicamentos fitoterápicos no país. A intenção é tratar de modo diferenciado medicamentos resultantes de plantas de uso tradicional. Com isso, os fitoterápicos que constarem na lista elaborada pela Anvisa poderão ter a eficácia e segurança aprovadas com base nos relatos da literatura científica sobre o uso tradicional. A medida vai permitir que medicamentos importantes, mas que vinham perdendo espaço no mercado, sejam resgatados, valorizando a biodiversidade do Brasil. Atualmente, determinadas substâncias não conseguem se enquadrar nas exigências para o registro de medicamento, mesmo tendo um histórico conhecido e positivo de uso pela população.
A Anvisa espera que, a partir da discussão em torno da proposta, os usuários possam ter acesso a um conjunto maior de opções terapêuticas. A medida vai representar, também, um estímulo à indústria nacional de fitoterápicos.
Depois da aprovação da iniciativa regulatória pela diretoria, o próximo passo será a publicação de uma Consulta Pública para discussão com todos os interessados no tema.
Portal da Anvisa (adaptado).
Leia o trecho abaixo, transcrito do segundo parágrafo, e, em seguida, assinale a alternativa cujos termos destacados tenham, respectivamente, a mesma classificação morfológica dos destacados no período abaixo.
A medida vai representar, também, um estímulo à indústria nacional de fitoterápicos.
Provas
Questão presente nas seguintes provas
Read the paragraph below to answer question.
An increased incidence of kidney stones and renal failure in infants has been reported in China, believed to be associated with the ingestion of infant formula contaminated with melamine. It has been discovered that melamine has been deliberately added to raw milk for a number of months in order to boost its apparent protein content. In 2007 there was a large outbreak of renal failure in cats and dogs in the USA associated with ingestion of pet food found to contain melamine and cyanuric acid. Melamine alone is of low toxicity; experimental studies have shown that combination with cyanuric acid leads to crystal formation and subsequent kidney toxicity.
Choose the alternative that fills in correctly the blank of the sentence below.
“Melamine alone is of low toxicity; experimental studies have shown that combination with cyanuric acid leads to crystal formation and subsequent kidney toxicity”.
World Health Organization, 30/10/2008.
Provas
Questão presente nas seguintes provas
Read the paragraph below to answer question.
The alarm Europe the discovery horse meat beef products escalated again Monday, when the Swedish furniture giant Ikea withdrew an estimated 1,670 pounds meatballs sale 14 European countries. Ikea acted after authorities in the Czech Republic detected horse meat in its meatballs. The company said it had made the decision even though its tests two weeks ago did not detect horse DNA. Horse meat mixed with beef was first found last month in Ireland, then Britain, and has now expanded steadily across the Continent. The situation in Europe has created unease among American consumers over or not horse meat might also find its way into the food supply in the United States.
(The New York Times, 2/25/2013)
Based on the text, it is correct to affirm that
Provas
Questão presente nas seguintes provas
Read the paragraph below to answer question.
The alarm Europe the discovery horse meat beef products escalated again Monday, when the Swedish furniture giant Ikea withdrew an estimated 1,670 pounds meatballs sale 14 European countries. Ikea acted after authorities in the Czech Republic detected horse meat in its meatballs. The company said it had made the decision even though its tests two weeks ago did not detect horse DNA. Horse meat mixed with beef was first found last month in Ireland, then Britain, and has now expanded steadily across the Continent. The situation in Europe has created unease among American consumers over or not horse meat might also find its way into the food supply in the United States.
(The New York Times, 2/25/2013)
According to the formal rule of the English language, choose the alternative that fills in correctly the blank of the sentence below.
“The situation in Europe has created unease among American consumers over or not horse meat might also find its way into the food supply in the United States”.
Provas
Questão presente nas seguintes provas
Read the paragraph below to answer question.
The alarm Europe the discovery horse meat beef products escalated again Monday, when the Swedish furniture giant Ikea withdrew an estimated 1,670 pounds meatballs sale 14 European countries. Ikea acted after authorities in the Czech Republic detected horse meat in its meatballs. The company said it had made the decision even though its tests two weeks ago did not detect horse DNA. Horse meat mixed with beef was first found last month in Ireland, then Britain, and has now expanded steadily across the Continent. The situation in Europe has created unease among American consumers over or not horse meat might also find its way into the food supply in the United States.
(The New York Times, 2/25/2013)
Choose the alternative that fills in, correctly and respectively, the blanks of the sentence below.
“The alarm Europe the discovery horse meat beef products escalated again Monday, when the Swedish furniture giant Ikea withdrew an estimated 1,670 pounds meatballs sale 14 European countries”.
Provas
Questão presente nas seguintes provas
Read the text below to answer question.
FDA seems to take light approach to Allergan and LAP-BAND
In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States. The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm. The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Today’s FDA isn’t that FDA.
Today's FDA can be steamrollered. Today's FDA just approved an application by Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients. Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record. In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed Botox for uses the FDA hadn't approved. In accepting the plea bargain, the government charged that the company had made under-thetable payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a neck spasm that affects only about 27,000 people. Allergan wanted doctors to prescribe Botox for headaches. Botox's sales grew 1,407% and by 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.
This didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach. So far, the approved use has been for morbidly obese people. An FDA advisory panel, which gave preliminary approval to Allergan's application, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which conducted by researchers with financial links to Allergan — but they felt that the Lap-Band's benefits outweighed the risks.
(HILTZIKLOS, M., Adapted from Los Angeles Times, 22/02/2011)
Read the sentence below
“Botox's sales grew 1,407% and by 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.”
It is correct to affirm that the underlined word refers to
Provas
Questão presente nas seguintes provas
Read the text below to answer question.
FDA seems to take light approach to Allergan and LAP-BAND
In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States. The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm. The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Today’s FDA isn’t that FDA.
Today's FDA can be steamrollered. Today's FDA just approved an application by Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients. Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record. In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed Botox for uses the FDA hadn't approved. In accepting the plea bargain, the government charged that the company had made under-thetable payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a neck spasm that affects only about 27,000 people. Allergan wanted doctors to prescribe Botox for headaches. Botox's sales grew 1,407% and by 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.
This didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach. So far, the approved use has been for morbidly obese people. An FDA advisory panel, which gave preliminary approval to Allergan's application, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which conducted by researchers with financial links to Allergan — but they felt that the Lap-Band's benefits outweighed the risks.
(HILTZIKLOS, M., Adapted from Los Angeles Times, 22/02/2011)
Read the sentence below and choose the alternative that correctly links the underlined words to the nouns they refer to.
An FDA advisory panel, (I)which gave preliminary approval to Allergan's application, wasn't entirely happy with the company's data supporting (II)its safety and efficacy claims for the Lap-Band— (III)its own 149-patient study and six other studies, at least three of (IV)which conducted by researchers with financial links to Allergan.
Provas
Questão presente nas seguintes provas
Read the text below to answer question.
FDA seems to take light approach to Allergan and LAP-BAND
In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States. The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm. The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Today’s FDA isn’t that FDA.
Today's FDA can be steamrollered. Today's FDA just approved an application by Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients. Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record. In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed Botox for uses the FDA hadn't approved. In accepting the plea bargain, the government charged that the company had made under-thetable payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a neck spasm that affects only about 27,000 people. Allergan wanted doctors to prescribe Botox for headaches. Botox's sales grew 1,407% and by 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.
This didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach. So far, the approved use has been for morbidly obese people. An FDA advisory panel, which gave preliminary approval to Allergan's application, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which conducted by researchers with financial links to Allergan — but they felt that the Lap-Band's benefits outweighed the risks.
(HILTZIKLOS, M., Adapted from Los Angeles Times, 22/02/2011)
Read the sentence below.
“Today's FDA can be steamrollered.”
Choose the alternative that presents the best synonymous to the underlined verb.
Provas
Questão presente nas seguintes provas
Read the text below to answer question.
FDA seems to take light approach to Allergan and LAP-BAND
In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States. The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm. The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Today’s FDA isn’t that FDA.
Today's FDA can be steamrollered. Today's FDA just approved an application by Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients. Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record. In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed Botox for uses the FDA hadn't approved. In accepting the plea bargain, the government charged that the company had made under-thetable payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a neck spasm that affects only about 27,000 people. Allergan wanted doctors to prescribe Botox for headaches. Botox's sales grew 1,407% and by 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.
This didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach. So far, the approved use has been for morbidly obese people. An FDA advisory panel, which gave preliminary approval to Allergan's application, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which conducted by researchers with financial links to Allergan — but they felt that the Lap-Band's benefits outweighed the risks.
(HILTZIKLOS, M., Adapted from Los Angeles Times, 22/02/2011)
According to the text, it is correct to afirm that
Provas
Questão presente nas seguintes provas
Read the text below to answer question.
FDA seems to take light approach to Allergan and LAP-BAND
In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States. The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm. The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Today’s FDA isn’t that FDA.
Today's FDA can be steamrollered. Today's FDA just approved an application by Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients. Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record. In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed Botox for uses the FDA hadn't approved. In accepting the plea bargain, the government charged that the company had made under-thetable payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a neck spasm that affects only about 27,000 people. Allergan wanted doctors to prescribe Botox for headaches. Botox's sales grew 1,407% and by 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.
This didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach. So far, the approved use has been for morbidly obese people. An FDA advisory panel, which gave preliminary approval to Allergan's application, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band— its own 149-patient study and six other studies, at least three of which conducted by researchers with financial links to Allergan — but they felt that the Lap-Band's benefits outweighed the risks.
(HILTZIKLOS, M., Adapted from Los Angeles Times, 22/02/2011)
According to the text, it is correct to affirm that
Provas
Questão presente nas seguintes provas
Cadernos
Caderno Container