New CDER SBIA Web-Based Learning Course:
Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND
CDER SBIA is pleased to announce the launch of yet another web-based learning course as part of our Small Business and Industry Education Series, titled the Chemistry, Manufacturing and Controls (CMC) Perspective of the Investigational New Drug Application (IND).
This course focuses primarily on the CMC information for IND submissions. We developed it to help IND sponsors become familiar with applicable CMC statues, regulations, and relevant documents. The course objectives include:
- Defining the different types of INDs
- Describing the general IND requirements
- Describing the general CMC requirements for INDs
- Distinguishing CMC information required for special categories
- Identifying comparator and placebo information for INDs
- Identifying good manufacturing practices during the IND stage
We hope that you find this course helpful and utilize it to learn about FDA requirements and recommendations regarding this topic.
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/