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.
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)
- And more…
For more info: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm631022.htm