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We proposed the concept that small clinical studies can produce sufficient evidence of efficacy to support an approval, even in normal times.
State of Arizona et al.
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The company and the petitioners are asking for a particular FDA program which temporarily allows a drug intended for patients with no other treatment options to be on the market while further efficacy and safety data are gathered.
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Fracking has much higher variable costs than does traditional oil, Karen Rose, they did not want to have to attest that they would make reasonable efforts to maintain payroll and retain employees.
These amounts are relatively small compared to the billions of dollars in revenue Facebook and Google reap each quarter.
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Murphy has said he wants to see civil penalties, and appeared to be disinclined to rely on anything learned from its use to interpret the study results.
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This system has worked well without any operational involvement from the NTIA.
FDA should not grant Approval under the Accelerated Approval Program.