Does FDA ask for the same scope of studies to qualify for pediatric exclusivity as it does to fulfill the requirements of the pediatric rule?
A18. No. For pediatric exclusivity, FDA will issue a Written Request for necessary studies on all of the indications that occur in pediatric populations for which an active moiety is used. A sponsor does not have to respond to a Written Request. However, a sponsor must supply all the information asked for in the Written Request to obtain pediatric exclusivity. At present, under the pediatric rule, FDA is requiring applicants to conduct a pediatric assessment only for drug products and indications contained in applications submitted for review. The application could be for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration. The Agency reserves the right to require studies on approved indications of a marketed drug as discussed above at Q17.
Related Questions
- Does FDA ask for the same scope of studies to qualify for pediatric exclusivity as it does to fulfill the requirements of the pediatric rule?
- Where can I get answers to questions that come up regarding FDAs implementation of the pediatric "Rule" provisions?
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