New Drugs To Market Flashcards
How long does the FDA have to decide on an IND?
30 days
How many phases of testing must occur before final approval?
3 phases
How many phases are there after the drug product has been marketed?
1 (phase 4)
What phase testing is in healthy individuals?
Phase 1
What phase establishes safety in humans?
Phase 1
What phase determines effectiveness?
Phase 2
What phase helps establish info about adequate dosing?
Phase 2
What phase of testing is large groups of people in several geographical locations?
Phase 3
What allows administration of a new drug to patients not enrolled in the new drugs clinical trial?
Treatment IND
What is a requirement of treatment IND?
Imminent life threatening illness with presently no cure
What phases just a drug be in for a treatment IND?
Phase 2 and 3
What point can the manufacturer market the new drug?
After approval of phase 1-3
What application is required for new generics?
Abbreviated NDA
What application allows manufacturers to make changes to a drug?
Supplemental NDA
Any changes made by the company that filed the original NDA will probably require what application?
Supplemental IND
If another company other than the original NDA holders file, it’s most likely what application?
Abbreviated NDA
What type of therapeutic classification shows a major therapeutic gain?
Type P
What type of therapeutic classification indicates that the drug is similar to other drugs in the market?
Type S
Who’s responsibility is it to designate generic names for new drugs?
U.S. Adopted Names Council
What must be filled out before administering a new drug to humans?
IND
What therapeutic equivalency code means they are considered therapeutically equivalent to other drugs?
A
What therapeutic equivalent code means these drugs have actual or potential bio equivalence problems that have it been resolved?
B
If two drugs contain sale active ingredient, are they therapeutically equivalent?
No
If pharmaceuticals equivalent, are they therapeutically equivalent?
No always
