- Is FDA planning to organize international training around quality by design?
- Training opportunities are part of the International Conference on Harmonization (ICH). FDA is putting together an implementation team for Q8, 9 and 10. FDA is also developing fact sheets for Q8, 9, 10, and a program that will standardize training throughout the world.
- How many design space applications has FDA approved?
- The Office of Generic Drugs has not done a complete design space. OGD has decided it needs to address design space issues in a rational, timely manner.
- Does FDA accept applications for change of manufacturing sites for formulation, not of the active pharmaceutical ingredient? Is this considered a completely new application?
- To clarify, the formulation is the same, but it is manufactured at a different site. The firm will need to provide additional data for this change. The data will be evaluated for bioequivalence and chemistry, and may undergo a compliance inspection. In addition, the company will have to redo its bioequivalence data to link it to the original application.
Lesson status: Incomplete (0% done)
Topic: page 5 of 5 (Lesson: page 26 of 27)