FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 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 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

Future Events

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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