If a sponsor submits a pediatric study that meets the terms of a Written Request but the study is not adequate for inclusion in the labeling, will the sponsor get pediatric exclusivity?
Related Questions
- If a sponsor submits a pediatric study that meets the terms of a Written Request but the study is not adequate for inclusion in the labeling, will the sponsor get pediatric exclusivity?
- Does a sponsor HAVE to conduct pediatric studies if it receives a Written Request from FDA?
- Can an applicant ask FDA to issue a Written Request for pediatric studies?
