Describe documentation required for initial IND submission and ensure Getafix understands the necessity of IND maintenance throughout drug development.
Outline operational and strategic considerations Getafix should take into account when preparing to submit its initial IND to the FDA. RGA 6101 – Therapeutic Product Development Spring 2023 Quarter Assignment: Based on the information provided below and discussed in class, prepare a 3 – 4 page report outlining recommendations for preparation and maintenance of an … Read more