Chapter13, prescriptiion drug submissions

Question 1

review time for proprietary name of the new drug for IND phase and NDA or BLA

Answer 1

180 days for IND phase , within days for BLA or NDA

Question 2

how many years or conditions will cause IND inactive

Answer 2

if no subjects were enrolled with in 2 years or no clinical holds are cleared in 1 year, the IND can be set to inactive upon sponsor request or FDA will

Question 3

How many years of inactive status of IND will make it terminated

Answer 3

5 years

Question 4

Sub acute toxicology studies requirements

Answer 4

Required in 2 mammals , one is non-rodent, mostly rats and dogs are selected

Question 5

Types of IND amendments

Answer 5

5
1 - protocol Amendment
2 - Information Amendment
3 - IND safety reports 15 day and 7 day
4 - IND Annual reports
5 - General correspondence

Question 6

What is Sentinel System

Answer 6

System developed by FDA to track safety of all drugs

Question 7

what type of meeting is pre - submission meetings

Answer 7

Type B meetings

Question 8

What is PLR

Answer 8

Physician labeling rule

Question 9

Time for FDA to determine whether the new drug application is complete to allow for a review

Answer 9

60 days