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Increased conservation and energy efficiency, reduced consumption and the expedited development of alternative energy sources are the only safe and sustainable energy options for the future.
Few would argue against the need for more research on Ebola and the expedited development of a cure; however, recent incidents in biocontainment laboratories and the proliferation of such facilities globally raise concerns about safety and have split the scientific community.
Moreover, the utility of this quantitative approach allows for the expedited development of cost effective MS assays.
42 Our study has certain limitations; in particular, in examining trends in the application of the expedited development and FDA review programs, we did not investigate individual outcomes from the drugs in our sample.
To test the involvement of glutamate receptors in the expedited development of kindling, we treated Fmr1 KO mice with the NMDA receptor antagonist MK801 or the mGluR5 antagonist MPEP.
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Main outcome measures Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs.
Having shown why some regulatory oversight is necessary in conditions of a pandemic, I next explore how therapeutic access to investigational new drugs might be further expanded beyond the policies of expedited development or parallel track without abandoning the need for good evidence of safety.
35 Less innovative products moving through the FDA's expedited development and review programs can divert limited governmental resources.
Finally, we also determined which of the four primary expedited development and review programs were associated with each drug: orphan, fast track, accelerated approval, and priority review (we did not study the breakthrough therapy designation because of its recent implementation 6).
Objective To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades.
37 Despite the growing application of expedited development and FDA review programs to new drugs, Congress continues to authorize more such pathways.
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