- Meet with the FDA to discuss and negotiate development strategies
- Prepare and submit:
- Pre-IND/IDE briefing documents
- IND and IND amendments
- IDE
- 510(k)
- NDA
- BLA
- PMA
- DMF
- Export requests
- Establishment registrations
- Orphan Drug requests
- Interact with legal counsel
- Assure that user fee monies are submitted on schedule
- Follow up with FDA on post-NDA submission questions
- Perform pre-inspection GMP audits
- Support responses to FDA questions and warning letters
- Adverse event monitoring and reporting
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