Exam (elaborations)
SOCRA QUESTIONS AND ANSWERS 2022/2023
- Course
- Institution
When isn't an IND application needed? - Answer - IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) - Answer - -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Pla...
[Show more]