This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) review process. Presentations will focus on various aspects from pre-ANDA, drug development, post-marketing and global generic drug affairs program support for the generic drug program.
INTENDED AUDIENCE
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
prepare regulatory submissions
FDA RESOURCES
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