Submission Type: Original Application Submission ID: 125335/0 Office: OBRR
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Vaccines, Blood & Biologics
Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine)
Instituto Bioclon, S.A. de C.V.
Telecon Date/Time: 08-JAN-2010 12:00 AM Initiated by FDA? Yes
Author: DEBRA CORDARO
Suggestions to postpone meeting
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
---(b)(4)---- was informed that an internal meeting was held to prepare the Agency’s responses to the firm’s questions. During that meeting, it was determined that significant additional information was needed from the firm before FDA could answer the posed questions; without this new information, it is unlikely that the meeting objectives can be met.
It was suggested to Bioclon that they postpone this meeting and submit the information that will be requested in our proposed answers. FDA was willing to reschedule the meeting approximately two weeks after the additional information is received. Bioclon agreed to postpone the meeting; no new meeting request will be needed.