Listen as we discuss the Clinical Trial Label Requirements and strategy as well as label text requirements.
Having multiple clinical sites in more than two countries does not always require booklet labels. The optimal label type depends on multiple label considerations such as drug & placebo levels, returns & destruction, and expiry date. In this audio recording, we discuss label strategy as well as label text requirements such as:
- Annex 13 and Annex 6 requirements
- US label text requirements and implications
- What label considerations should be taken into account when the study is being designed