This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications.
Who should attend?
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
Plan to submit an ANDA or are in the process of submitting an ANDA
Involved in generic drug development
Work on bioequivalence, stability, dissolution and impurity testing
Submit Drug Master Files (DMFs)
Prepare regulatory submissions
After this course, attendees will be able to:
Discuss requirements for an ANDA
Understand and determine when to use a reference listed drug or a reference standard
Determine the types of FDA meetings and when to use controlled correspondence
Understand the factors resulting in an FDA refusal to receive decision
Identify common deficiencies in ANDAs including bioequivalence and quality (e.g. stability, dissolution and impurity testing)
Avoid common errors related to the Drug Master File (DMF)