The use of an already approved drug for condition X, studied to become FDA appro
ID: 84121 • Letter: T
Question
The use of an already approved drug for condition X, studied to become FDA approved for the treatment of another disease? A) Black Box B) Open-label C) Off-label D) Double-blind After all clinical trials are completed, a sponsor of the dug submits a ___________ to the FDA for FINAL approval? A) IND B) NDA. C) Patent Board D) IRB A Phase I clinical trial is focused on A) Efficacy B) Safety C) the lowest cost trial D) IND __________ is given to drugs for serious and life-threatening illnesses that lack satisfactory treatments? A) Orphan Status B) Black Box warning C) Acclerated Approval D) Phase IV trial Generic drug: comparable to an innovator drug in dosage from, strength, route of administration, quality, performance characteristics & intended use. It must demonstrate? A) Bioefficacy B) Dose scheduling C) Bioequivalence D) Pharmacokinetics An Orphan Drug A) is to treat rare disease B) can be sold commercially after a Phase II C) Both A and B generic D) None of the above- it is a genericExplanation / Answer
28)c)Off-Label
29)a)IND
30)b) safety
31)c)Accelerated approval
32)c) bioequivalence
33)a) is to treat rare disease.
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