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| Contact |
800 Enterprise Road, Suite 200
Horsham, Pennsylvania
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| Description |
This is a modified version of two three-day courses combined into one extended four-day course. This course describes the regulatory background of the IND and NDA, and an overview of requirements and recommendations for preparing these applications for submission to the FDA.
Key Topics
Overview of FDA
Regulatory requirements for drug development and approval
Post-approval and marketing regulatory requirements and processes
Overview of the CTD format.
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