The Art of Filing NDA/ANDA and Biologics License Application (BLA) and Post-Approval Changes to the FDA

Duration - 47 Minutes

Price - INR-2000 / USD-70
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About the course

  • Factors that have an impact on ANDA and BLA submissions
  • Determining the type of PMA submission and equivalent NDA/ BLA submission
  • User interface of a combination product submitted in an ANDA and identify commonly issued deficiencies
  • Changes to an approved NDA or ANDA and the type of submission required

Speaker Profile

Dr. María José Barragán

Barragan BioConsulting and Former FDA

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