USFDA has updated Manual of Policies and Procedures Document Titled "Chemistry Review of Question-based-Review (QbR) of Submissions".
To Download the Document Please CLICK HERE
Showing posts with label CMC. Show all posts
Showing posts with label CMC. Show all posts
New CDER SBIA Web-Based Learning Course : Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND
CDER SBIA has announced 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.
To Start you Web-Based Learning Course CLICK HERE
For other Courses offered under Small Business and Industry Education Series CLICK HERE
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