Create an account
1. Determine whether a drug is safe/effective.
2. Drug package insert is appropriate.
3. Whether the methods used in manufacturing the drug are adequate to preserve the drug's identity, strength, quality, and purity.
What are the goals of NDA?
Contains data for the review and ultimate approval of a generic drug product.
What is the purpose for ANDA?
Provides support to the pharmaceutical/biotechnology industries in the form of outsourced pharmaceutical research services.
What are CRO's?
70% of INDs. (Investigational New Drug)
What is the percentage of all new drugs that pass in PHASE I?
Phase II and Phase III
_______ and ________ are combined to shorten approval process on new medicines for serious and life-threatening diseases.
Verifying effectiveness monitor adverse reactions from long-term use.
What is the purpose of PHASE III?
Large scale manufacturing, Distribution and Education.
The purpose of phase IV is ________, ________, and ______
Patent extension. (for up to 5 years for time lost in "review")
The drug price competition and patent term restoration act provides ________.
The 6 month marketing exclusivity was extended to the first company that conducted the clinical studies and obtained FDA approval for the pediatric
indication is called _________.
Please allow access to your computer’s microphone to use Voice Recording.
Having trouble? Click here for help.
We can’t access your microphone!
Click the icon above to update your browser permissions and try again
Reload the page to try again!Reload
Press Cmd-0 to reset your zoom
Press Ctrl-0 to reset your zoom
It looks like your browser might be zoomed in or out. Your browser needs to be zoomed to a normal size to record audio.
Please upgrade Flash or install Chrome
to use Voice Recording.
For more help, see our troubleshooting page.
Your microphone is muted
For help fixing this issue, see this FAQ.
Star this term
You can study starred terms together