Curriculum
Course Description:
- Formal risk assessment is a natural progression of the FDA 21st Century Quality Initiative.
- Formal risk management approaches are being used in Abbreviated New Drug Application (ANDA) review to ensure that all high-risk areas receive appropriate scrutiny to ensure the availability of high-quality generics.
- Mitigation of high-risk areas may necessitate stringent controls of critical material attributes of excipients.
- Formal risk management will also streamline the review of lower-risk areas to ensure review timelines under the reauthorized FDA Generic Drug User Fee Amendments.
Featuring Andre Raw, Ph.D., U.S. FDA
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.