End of Phase 2 Meeting (Cont.)
Potential topics for review of phase 1 and 2 safety data include:
- Safety signals
- Preliminary efficacy in the intended population
- Early risk/benefit evaluation
- Phase 3 studies
Sponsor may also discuss whether additional CMC data would be required
- Will the characterization of drug product to be used in studies be the same as the to-be-marketed product?
- Will there be bridging data?
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