Regulatory Education for Industry (REdI): Generic Drug Forum – April 3 & 4, 2019
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 [...]