That would mean clear evidence about Vytorin's safety and effectiveness might never be obtained.
Although some might swear by these remedies, scientific evidence of their safety and effectiveness is lacking.
The safety and effectiveness of Xarelto for the new indications were evaluated in three clinical studies.
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Merck and Schering have stood resolutely behind the safety and effectiveness of Zetia and Vytorin.
Two clinical studies involving 1, 684 patients with lupus demonstrated the safety and effectiveness of Benlysta.
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We still do not know how these two drugs compare in safety and effectiveness.
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Questions surrounding the safety and effectiveness of supplements do not seem to have deterred consumers.
It warned of a shortage of evidence about the safety and effectiveness of the procedure.
Clinical trials would be needed to test the safety and effectiveness of the treatment, he added.
The safety and effectiveness of Kynamro were evaluated in a clinical trial of 51 patients with HoFH.
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Currently much data that are relevant to the safety and effectiveness of approved drugs are beyond public view.
But prosecution would be "greatly aided" by strengthening the law that governs safety and effectiveness of drugs, Maher said.
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The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH.
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The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.
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The safety and effectiveness of JUXTAPID have not been established in pediatric patients.
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Wales' chief medical officer, Dr Tony Jewell said he was very concerned about the safety and effectiveness of those vaccines.
Warheads will be tested by technical means to ensure their safety and effectiveness, without having to test them by explosion.
The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness.
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The association supports reclassifying ECT devices as medium risk, which would preclude the need for additional research regarding their safety and effectiveness.
Merck (nyse: MRK - news - people ) and Schering have stood resolutely behind the safety and effectiveness of Zetia and Vytorin.
The trials will measure the safety and effectiveness of the vaccine.
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The FDA and Vivus both acknowledge that the three clinical trials meant to measure Qsymia's safety and effectiveness were not designed to properly assess cardiovascular risk.
Drug firms get a 20-year monopoly on new chemicals they invent, but at least half that time is usually eaten by tests to prove safety and effectiveness.
Researchers hope that if the ongoing preliminary studies prove the safety and effectiveness of these drugs for certain treatments, the government will step in to fund larger trials.
Safety and effectiveness have not been established in pediatric patients.
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What is most sad about critics such as Dr. Salzberg is their apparent decision that safety and effectiveness take a back seat to their opinion of current science protocols.
If the second results are as promising, a third set of trials will be carried out to provide evidence to drug authorities of the safety and effectiveness of the treatment.
To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.
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The agency can leave ECT devices in their current class and require manufacturers to provide evidence of safety and effectiveness, which may entail new clinical trials and could temporarily limit the devices' use.
Vytorin is being tossed about by a larger political storm centered on how much evidence doctors should require about a drug's safety and effectiveness and how much risk patients should expect every time they swallow a pill.
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