FDA Drug Approval Process February 2011

Course Description 

This course provides an overview of what is required to take a new drug from research to market. We will begin by reviewing the contents of an IND, and then follow the process of an IND submission. From there, we will discuss the contents and approval process of an NDA submission. This course will provide a foundation for those who require an understanding of the FDA new drug approval process, and help attendees become familiar with the regulatory landscape in which INDs and NDAs are developed and approved.



Learning Objectives 

  • Navigate the FDA approval process for a new drug
  • Describe what an IND is, and identify the contents of an IND
  • Describe what an NDA is, and identify the contents of an NDA
  • Discuss the FDA IND and NDA review process

Who Should Attend 

  • Regulatory Affairs personnel, Quality personnel, Manufacturing personnel, Research personnel, Those who have to know about preparation of INDs and NDAs, Those who have to understand the FDA new drug approval process


Albert A. Ghignone, MS, RAC

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Course Length Time 

3 hours; 12:30 - 3:30 p.m. Eastern

Course Dates 

February 1, 2011

Registration Fees