Clinical trials fast-track

Clinical Trial Application (CTA) has to be submitted to Health Canada seeking permission to conduct clinical trials. The submission should include information regarding drug characteristics, test data, animal studies, and clinical protocol. A clinical trial may be stopped when either it is shown to be unsafe or dramatic benefits are obtained. The approval process may be fast-tracked if a drug is shown to have substantial benefits, such as for treatment of life-threatening or severely debilitating conditions. 

In the not too distant future, Insulin intake will become even easier. Thanks to a new insulin inhaler, by Generex, insulin injections may become relics of the past. The inhaler sprays insulin out into the mouth like a mist, which coats the membranes of the mouth, throat and tongue. The insulin then passes quickly through the membranes into the bloodstream. The new insulin inhaler is in phase two clinical trials. If all goes well, the Food and Drug Administration could put it on a fast track for approval, making it available on the market in less than two years. 

C. difficile and is in Phase II clinical trials for the treatment of CDAD and VRE infections. CDAD indication received Fast Track status from the FDA. ... 

Recently (1996) the FDA (U.S.) has given fast track approval to three peptidomimetic HIV-protease inhibitors. These agents were released based on fewer and shorter clinical trials than would be required if the urgency of AIDS were not so acute. As a result, drug interactions and adverse effects are not fully known at this time. 

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