Block I - Drug Design Flashcards
1
Q
Process from newly discovered drug to market
A
Preclinical research -> IND -> Phase 1/2/3 clinical trials -> NDA -> FDA review -> FDA safety monitoring -> Post market surveillance
2
Q
IND
A
Application for Investigational New Drug before human research.
3
Q
NDA
A
New Drug Application to request approval to market drug.
4
Q
DEA
A
Established to enforce and update laws on controlled substances
5
Q
Controlled Substance Act
A
Regulations for manufacture, possession, distribution, use of various drugs. Contains schedules classifying potential drugs of abuse.
6
Q
FDA Adverse Drug Event reporting system
A
MedWatch - voluntary reporting of adverse events
