FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019
23 May 2019
Webinar
Description
Topics
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
Who should Attend
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
Past Events
FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019 - 23 May 2019, Webinar (84321)
Important
Please, check "FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs" official website for possible changes, before making any traveling arrangements
