19 min
Part 2 - Abbreviated New Drug Applications: Fundamentals, Challenges, and Agency Communication Chasing Compliance: The Global Regulatory Podcast
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- Science
This episode is Part 2 of a two-part episode on Abbreviated New Drug Applications (ANDAs). We continue our conversation with our ANDA expert Sandra Kircus. In this part, Sandra provides advice on how to manage ANDA projects, the importance of strong project management, and provides suggestions for project management tools. She also shares her thoughts on how to regulatory leaders can optimize the ANDA writing process and how to optimize the ANDA process fro companies outside of the United States referred to as xUS companies. Sandra and Jamie discuss why having strong US agent for xUS companies is important. While this advice is focused on xUS companies, it also rings true for US companies as well.
2:30 – Tips for general approach to writing ANDAs
Make sure you understand what the agency is looking forStay focused, don’t give the FDA more than they need or that they are asking for. The level of detail in your regulatory documentation doesn’t need to match the level of detail in your technical documentation. Give yourself flexibility.
5:40 – Tips for the ANDA writing process
Put effort into the program management aspectMake sure all contributors and stakeholders are alignedHave periodic discussions with the teamGet 1:1 time with the team to discuss the project and specific sections
8:00 – Software for Program Management
10:30 – Proportion of applications from US companies and outside or xUS companies. Implications for xUS companies and role of US agents.
This episode is Part 2 of a two-part episode on Abbreviated New Drug Applications (ANDAs). We continue our conversation with our ANDA expert Sandra Kircus. In this part, Sandra provides advice on how to manage ANDA projects, the importance of strong project management, and provides suggestions for project management tools. She also shares her thoughts on how to regulatory leaders can optimize the ANDA writing process and how to optimize the ANDA process fro companies outside of the United States referred to as xUS companies. Sandra and Jamie discuss why having strong US agent for xUS companies is important. While this advice is focused on xUS companies, it also rings true for US companies as well.
2:30 – Tips for general approach to writing ANDAs
Make sure you understand what the agency is looking forStay focused, don’t give the FDA more than they need or that they are asking for. The level of detail in your regulatory documentation doesn’t need to match the level of detail in your technical documentation. Give yourself flexibility.
5:40 – Tips for the ANDA writing process
Put effort into the program management aspectMake sure all contributors and stakeholders are alignedHave periodic discussions with the teamGet 1:1 time with the team to discuss the project and specific sections
8:00 – Software for Program Management
10:30 – Proportion of applications from US companies and outside or xUS companies. Implications for xUS companies and role of US agents.
19 min