Lecture 2 Flashcards
1
Q
CTA
A
clinical trial application
2
Q
NDS
A
new drug submission ( TO obtain a license of a new drug
-called NDA in the US
-Called MAA in Europe
-takes about 300 days
3
Q
SNDS
A
Supplemental new drug submission (to make substantial changes to a drug that already has a notice of compliance (NOC)
4
Q
ANDS
A
abbreviated new drug submission
-To market a generic drug. Demonstrate that the drug is as safe and efficacious as the brand-name drug.
5
Q
NOC
A
notice of compliance with conditions
- Qualifying Notice letter
Letter of Undertaking
NON: Notice of Non-Compliance
NOD: Notice of Deficiency
6
Q
DIN
A
Drug identification number
