Card Set Information
What is the NDA?
The New Drug Application, which is submitted to the FDA. It is the application submitted for marketing approval.
What is Phase I of the NDA Process?
Phase 1 consist of a small group of healthy volunteers where they are tested for the maximum tolerance of the drug.
What is Phase II of the NDA process?
Phase II involves the diseased large group of people to test the effectiveness of the drug.
Whats is Phase III of the NDA Process?
Phase III is the final test before the application is submitted to the FDA. It consist of many trials in several facilities and often test the drug against other drugs for relative effectiveness.
What is Phase IV of the NDA Process?
It is the Phase after the drug has been approved by the FDA. At this time, the drug is examined for any possible side affects.
What is the average amount of time it takes for a drug to be approved?
Between 12-16 years
What is the INDR?
The Investigational New Drug Review is a process of application to be able to ship unapproved drugs across state lines.