What is the fine-grained topic of the following text: "We believe that one adequately designed and well-controlled clinical study (as described above), or other clinical exposure in children not previously contemplated under FDA's prior rule, should be sufficient to fulfill the FDAMA exclusivity provisions on pediatric studies and that Rx and OTC drugs should be treated equally in this regard," NDMA maintains. Only return the topic.
NDMA's stance on pediatric studies for drug exclusivity provisions