Definition of Pre-BLA Meeting


Pre-BLA Meeting means a meeting with FDA, the primary purpose of which is to uncover any major unresolved problems, to identify those studies that the sponsor is relying on as adequate and well-controlled to establish the drugs effectiveness, to identify the status of ongoing or needed studies adequate to assess pediatric safety and effectiveness, to acquaint FDA reviewers with the general information to be submitted in the marketing application (including technical information), to discuss appropriate methods for statistical analysis of the data, and to discuss the best approach to the presentation and formatting of data in the marketing application, as further defined in 21 C.F.R. 312.47(b)(2), as amended from time to time, or the corresponding foreign equivalent.
Sample 1