Drug Discover & Clinical Trial Flashcards
1
Q
What is the difference b/t drug withdrawal and recall?
A
- Withdrawal=unacceptable toxicity or new adverse rxns
- Recall=temporary removal of drug from market
2
Q
What are the classes of drug recall, from least serious to most serious?
A
least serious=class III (use of drug unlikely to cause adverse health consequences), most serious=class I (reasonable probability drug will cause serious adverse health consequences)
3
Q
Are physicians still bound by the package insert of a drug?
A
No, they can prescribe drugs for any purpose deemed reasonable. However, insurance companies will likely NOT reimburse for “off label” indications.
