Does a sponsor HAVE to conduct pediatric studies if it receives a Written Request from FDA?
A4. No. A company is not required to do the studies requested by FDA in a Written Request if it chooses not to do so. If, however, the applicant decides to conduct studies that differ from those described in the Written Request, the applicant will not qualify for pediatric exclusivity upon submission of the reports thereof. Applicants who choose to deviate from the studies described in the Written Request and who are interested in obtaining pediatric exclusivity should contact the review division and seek to amend the Written Request prior to the conduct of the studies. The applicant must receive an amended Written Request prior to submission of the study reports to NDA.
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?
