In today's dynamic regulatory environment, marked by potential organizational shifts and unpredictable timelines at the FDA (including PDUFA dates, PIND meetings, and center consolidations), efficient and strategic drug development in the Value-Added Medicines/505(b)(2) (VAM) space is paramount. Companies face increasing pressure to adhere to internal timelines and manage expenses effectively.
505(b)(2) Right-First-Time Strategy for Today's FDA is a timely Value-Added Medicines (VAM) webinar, sponsored by RRD Biopharma Development. The webinar will delve into recent real-world experiences and provide crucial insights for navigating these challenges and avoiding common pitfalls in VAM development. Our expert panel will discuss practical strategies to mitigate risks associated with regulatory uncertainty and ensure successful product development.
Key topics covered will include:
Join us on Wednesday, May 21, 2025, to gain actionable insights and strategies to confidently navigate the evolving FDA landscape and drive successful VAM drug development programs.
505(b)(2) Right-First-Time Strategy for Today's FDA is a timely Value-Added Medicines (VAM) webinar, sponsored by RRD Biopharma Development. The webinar will delve into recent real-world experiences and provide crucial insights for navigating these challenges and avoiding common pitfalls in VAM development. Our expert panel will discuss practical strategies to mitigate risks associated with regulatory uncertainty and ensure successful product development.
Key topics covered will include:
- Understanding the current FDA landscape and potential near-term disruptions.
- Addressing challenges related to unpredictable regulatory timelines (PDUFA, PINDs, etc.).
- Leveraging recent experiences to anticipate and overcome obstacles in the 505(b)(2) pathway.
- Implementing proven strategies to avoid costly pitfalls and maintain development momentum.
Join us on Wednesday, May 21, 2025, to gain actionable insights and strategies to confidently navigate the evolving FDA landscape and drive successful VAM drug development programs.
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