Scenarios

Decide how to classify a post-approval change in the EU

When can you start dosing under an IND?

Classify a protocol change in the EU

Choose the correct lifecycle operation for an updated document

Pick the best FDA meeting type for a narrow question set

Know what must happen after accelerated approval

Choose DCP or MRP based on whether you already have an MA

Know how applicants reference confidential DMF information

Pick the best content for a 483 response

Choose the right reduced stability design concept