Beware of Underestimating The Value Of A Pre-NDA Meeting
Source: Premier Research
By Lisa Crose

Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission of a well-organized NDA that fits the expectations of agency reviewers.
This blog covers the benefits and how to prepare for a pre-FDA meeting, what should be in your pre-NDA briefing package, potential topics for discussion as well as who should attend the pre-NDA meeting.
VIEW THE ARTICLE!
Log In
Signing up provides unlimited access to:
Free Sign Up

Signing up provides unlimited access to:
- Trend and Leadership Articles
- Case Studies
- Extensive Product Database
- Premium Content
HELLO. PLEASE LOG IN.
X
Not yet a member of Clinical Leader? Register today.
ACCOUNT SIGN UP
X
Please fill in your account details
ACCOUNT SIGN UP
Premier Research
This website uses cookies to ensure you get the best experience on our website. Learn more