FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019

  • 23 May 2019
  • Webinar

Description

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

Past Events

Important

Please, check "FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma

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