An opportunity exists to submit portions of the NDA submission for FDA review instead of waiting for the entire submission to be prepared. This approach must be requested by the sponsor and approved by FDA prior to submission. Rolling submissions are granted by the FDA only in situations where the public health can benefit from rapid product approval. In general, only complete portions of the chemistry and manufacturing section, the pharmacology and toxicology section, or the clinical section of the submission would be accepted in a "rolling" fashion. A rolling submission allows the FDA to review some portions of a submission while the sponsor is completing others, allowing for a faster overall FDA review time.
Was this article helpful?