This provides the FDA with the protocols to be used to move to live, human testing. Okayed unless FDA says no in 30 days. The large numbers of people involved helps make effectiveness findings more specific and brings infrequently occurring safety problems into view. Here the results of all previous work on the drug are compiled and presented to the FDA for permission to actually market the drug. B. General Points.
Human subjects are always volunteers.
Orphan drugs are a problem. Ethical aspects of placebo-control studies. C. Speeding up the Process 1. Allow for Treatment INDs. This is often used when a drug is the only one available to treat a condition.