RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125197/0 Office: OCTGT
Telecon Date/Time: 23-Apr-2010 01:30 PM Initiated by FDA? Yes
Author: LORI TULL
SPL dosage units, PMC proposal, and label revisions
FDA Participants: Kimberly Benton, Wilson Bryan, Lori Tull
Non-FDA Participants: Elizabeth Smith, Jonathan Gaynor, James Whitmore, Helen Kim
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FDA informed Dendreon that the SPL dosage units were not yet in the system, but should be by next week. FDA will notify Dendreon as soon as the units have been entered. FDA recommended that the units be 50 million CD54+ cells in 250mL. Dendreon asked if the antigen needed to be listed since it was considered an active ingredient. FDA responded that a unit would not be needed for the protein.
FDA informed Dendreon that the SPL did not need to be ready before approval, but by the time of product distribution. Dendreon noted that they were working to be able to implement the package insert within 24 hours of approval for physician training. FDA responded that they thought this would not qualify as distribution of the product, so it would be acceptable.
FDA stated that they agreed with Dendron’s proposal for the CMC PMC submitted in amendment 49. Regarding Dendreon’s request for a waiver for submission of lot distribution reports every six months, FDA stated that they would not grant this request because the information was needed for entry in the OBE database. FDA did not feel that submission of these reports would be burdensome to Dendreon.
FDA asked if Dendreon had concerns regarding the label revisions communicated in today’s email. Dendreon agreed to the revisions and committed to emailing a final clean copy of the agreed upon label this afternoon and following with a submission to the BLA.