Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval

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Achieving ANDA Success
Working with the FDA to Win First-Cycle Approval

Are you hoping for a one cycle approval of your ANDA?

This report explains how to meet the challenges and avoid the pitfalls in pursuing first-cycle ANDA approval including:

  • Advice on how to approach the FDA for guidance before you file your ANDA

  • How to work with Drug Master File holders and API suppliers to make the ANDA process go smoothly

Order your copy of Achieving ANDA Success: Working with the FDA to Win First-Cycle Approval today — applicants who get it right the first time can get their products to market quicker.

Order Your Copy Today

 

PDF Edition

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PDF Edition — $397

Who Will Benefit

  • Generic drug manufacturers
  • API suppliers
  • Submission and applications specialist
  • Strategic planning and lifecycle management specialists
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry
  • Regulatory professionals
  • Consultants/service providers

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