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Record of Telephone Conversation, June 3, 2010 - Anascorp
Submission Type: BLA Submission ID: 125335/0 Office: OBRR
Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine)
Instituto Bioclon, S.A. de C.V.
Telecon Date/Time: 03-Jun-2010 11:00 AM Initiated by FDA? Yes
Author: DEBRA CORDARO
To address clinical question from meeting request
FDA Participants: Hon-Sum Ko, M.D., Robert Fisher, Ph.D., Debbie Cordaro
Non-FDA Participants: ---------(b)(4)------------, Walter Garcia, M.D., Milton Ellis, Jennifer Spinella, ---------(b)(4)---------
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
A meeting was held between Bioclon and FDA on November 18, 2009 to discuss clinical issues in the complete response letter dated July 23, 2009. Another meeting was requested and scheduled for January 21, 2010. It was mutually agreed that the firm had not provided sufficient information for FDA to provide adequate responses to all questions, and the meeting was cancelled. However, on January 21, 2010, FDA provided preliminary responses, wherever possible, including one on clinical data submission, to Bioclon’s questions. At Bioclon’s request, a meeting has been scheduled on July 15, 2010 to address other issues in the Complete Response letter. FDA requested this teleconference to resolve the one clinical issue in the meeting request.
In the FDA preliminary responses to Bioclon’s questions for the January 21, 2010 cancelled meeting, it was stated that if the firm had difficulty in completing an integrated safety analysis report with a 90-day cutoff prior to resubmission, they were to provide justification for a longer cutoff date. In the meeting request for the July 15, 2010 meeting, Bioclon asked for a 180-day cutoff. FDA asked Bioclon to provide their reasoning for a 180-day cutoff time for the integrated safety report.
Bioclon detailed the time required to update the safety data from case report forms and prepare/review the report. In particular, there is an approximate six-week period required to query back and forth with the clinical investigator. There are 23 sites in the Arizona area. FDA recognizes the efforts made by the firm to update the safety database and acknowledges the 90-day cutoff may be difficult for them to meet. Citing 21 CFR 314.50, FDA stated the requirement, at least for NDAs, but also accepted by firms for the submission of an original BLA application, to provide a 120-day safety update after submission. FDA noted Bioclon’s request for a 180-day cutoff, but stated a 120-135 day cutoff may be reasonable; the cutoff for safety data may not exceed 135 days.
Bioclon agreed and would push their timelines and monitors to meet the cutoff of 120 days. FDA also agreed and would deem it acceptable if there are delays that render the cutoff within 135 days of resubmission.