ANDA Submission and GDUFA Final FDA Guidance 2019

Topics

• The FDA’s process for classifying major, minor, and unsolicited amendments to ANDAs or PASs
• Purpose and scope of GDUFA II
• The FDA review goals for amendments under GDUFA II
• The amendment format and submission process
• How ANDA or PAS deficiencies cause the FDA to request a major amendment or classify deficiency responses as a major amendment
• How the FDA will process amendments submitted before GDUFA II
• How high quality standards are maintained through inspections and risk-based approaches
• How to request the FDA to reconsider classifying a major amendment
• How amendment submissions may affect review goal dates
• The process of and reasons for requiring the identification of the facilities involved in the manufacture of generic drugs and the associated Active Pharmaceutical Ingredients (APIs)

Who should Attend

• Project managers
• Compliance and regulatory affairs professionals
• R&D staff
• QA & QC managers
• API manufacturers
• Generic drug manufacturers
• Consultants
• ANDA sponsors
• Generic drug industry professionals
• Directors, associate directors and associates