Table of Contents
Clinical Considerations in Generic Drug Development
Areas of Consideration
Reasons for Current Backlog
Clinical Review Team
Protection of Human Subjects
Control Documents
Phone Call or Control Document?
Clinical Endpoint Studies Protocol Development
When is a Bio-IND Required?
ANDA Submissions with Clinical Endpoint Studies
Reasons for Delays in Current ANDA Reviews
Ways to Facilitate Review Process
Pediatric Exclusivity Activities
“Other” Clinical Activities
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