FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019 is a webinar that covers topics such as:
- Definitions
- Applicable Statute(s) and Regulations
- Categories Approvable under 505(b)2
- Common Misconception
- 505(b)2 Applications: Contents
- 505(b)2 Requirements
- Drug Examples Approved under 505(b)2
- CMC Requirements under 505(b)2
- Important Considerations
- Injectable Biologics Approved under 505(b)2
- PASS-IT Recommendations: Best Practices
FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019 is intended for:
- VPs
- CEOs
- Attorneys
- Compliance Officers
- Clinical Affairs
- Regulatory Affairs
- R&D
- Quality Assurance
- Contractors/Subcontractors
- Consultants
- Anyone Interested in the FDA Drug Review and Approval Processes