Obtaining marketing approval for a generic drug requires good data and a clear understanding of the regulatory milestones that need to be met and when that needs to happen. Without both aspects, your generic drug application has little chance of remaining on schedule.
Most ANDA applications are rejected by the FDA on the first pass through the Agency, resulting in loss of both time and money. For many reasons, it pays to get your product approved as quickly as possible. How can you do that? The help of an experienced and reputable consultant is a great place to start.
Are you curious about any of the following:
- How is an ANDA different from an NDA?
- How to determine if your product needs a 505(j) or a 505(b)(2)?
- What are FDA's stability requirements?
- How can The Weinberg Group help me through the generic drug process?
The answers to these questions, plus a step-by-step guide through the entire approval process is all in our infographic. Download the infographic today to learn how to successfully navigate FDA's generic drug approval process.