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In the social sector there is a real poverty of efficacy data.
When a new biologic was produced, the manufacturer usually obtained data exclusivity to protect the clinical trial data for the medicine, including safety and efficacy data.
"Us saying that they should still be used in the absence of efficacy data knowing that they cause risks would be irresponsible".
That and other drugs are now bring rushed into production, ahead of efficacy data.
Each group may experience different effects from a particular drug, and requiring safety and efficacy data on each one, he told me, would further increase the costs of drug discovery and discourage new research.
Off-label marketing is prohibited partly because a nonapproved use of a drug often lacks the kind of safety and efficacy data required for an approved use of a drug.
Efficacy data will be available in 2001.
Efficacy data were available in 378 patients.
Some design issues also undermined the strength of efficacy data.
No comparative efficacy data exist for preschool children with asthma.
Figure 1 provides an overview of the efficacy data for these agents.
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