New CDER SBIA Web-Based Learning Course:
Engaging with the FDA During New Drug Development
CDER SBIA is pleased to announce the launch of the web-based learning course, “Engaging with the FDA During New Drug Development” as part of our Small Business and Industry Education Series.
This course focuses on familiarizing small pharmaceutical business and industry with resources available to communicate with FDA, and providing guidance on effectively interacting with FDA throughout the new drug development process. Throughout this course, we discuss:
- Paths of contact to engage with FDA
- The impact of formal meetings with FDA
- Types of formal meetings with FDA
- Questions to ask during formal meetings with FDA
- How to submit a meeting request and meeting package
- Tips for productive meetings with FDA
We hope that you find this course helpful and utilize it to more effectively interact with the Agency
We will post additional courses on our Small Business and Industry Education Series page as we develop them.
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
Please take our CDER Small Business survey: https://www.surveymonkey.com/