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Understand how to navigate complex generic drug approval pathways by determining whether to use an ANDA or a 505(b)(2) NDA.
| Hi E,
It is important to understand how to navigate complex generic drug approval pathways, and the first step is to determine whether your drug product should be submitted as an abbreviated new drug application (ANDA) for approval as a generic or if it requires submission of a 505(b)(2) new drug application. This particular issue is addressed in the FDA draft guidance "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This article will: |
| Provide an overview of the FDA draft guidance Help you understand when a 505(b)(2) application is appropriate and when an ANDA is appropriate Reference other draft guidance documents relevant to the topic including those focused on complex generics |
| Download the article to read more. |
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