Question-based review for CMC evaluations of ANDAs
- At: 2006 FIP Congress in Salvadore (Brazil)
- Type: Presentation
- By: RAW, Andre (Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, United States of America)
The Office of Generic Drugs (OGD) is developing a question-based review (QbR) for the Chemistry, Manufacturing, and Controls (CMC) evaluation of an Abbreviated New Drug Application (ANDA) that is focused on critical pharmaceutical quality attributes. The QbR will transform the CMC review into a modern, science and risk-based pharmaceutical quality.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.