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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Internal Meeting Minutes, November 17, 2009 - Spherusol

BLA 125354.0  
Monthly Review Team Meeting Minutes
November 17, 2009 3:00 PM – 4:00 PM WOC 1 CR 308 S

 
Attendees: Campbell, Karen M. (by phone), Cato, Dennis (by phone), Cowley, Siobhan (by phone), Daugherty, Jon, Jingyee, Kou, Miller, Catherine (by phone), Morris, Sheldon (by phone), Mosquera, Alexis, Schwartz, Ann, Wieland, Holly, Wise, Robert.
 
Purpose: The purpose of the meeting was for status updates for this BLA.
 
Brief Recent History: On October 8, 2009, the sponsor responded to a Deficiencies Identified (DI) letter sent on August 4, 2009, but some of his responses were inadequate, and would require further discussion. In addition a meeting with upper management staff was held on November 2, 2009, to determine an appropriate path to address the concerns with the proposed indication for this product. Dr. Daugherty agreed to prepare minutes for this meeting.
 
Current Status:
Dr. Morris summarized what was discussed at the November 2, 2009, meeting with upper management. There was agreement that the proposed indication, “assessing delayed-type hypersensitivity to Coccidioides immitis” was not medically useful and that upper management would support the issuance of a Complete Response (CR) letter and, that the CR letter should include a request to the sponsor to defend his proposed indication.
 
Some of the sponsor’s responses to the deficiencies identified were discussed at this November 17, 2009, meeting and were determined to be unacceptable. The Pharmacovigilance Plan (PCP) was unacceptable and this issue would be addressed in the CR letter mentioned previously.
 
The decision to add a nonclinical statistical reviewer has not been finalized. Dr. Kou indicated that she had tried to review the potency assay results but the data were not sufficient for her to do the potency assay analysis. It is possible that this may be included in the CR letter.
 
The proprietary name (PN) response was unacceptable and a PN CR letter will be issued. Dr. Daugherty agreed to prepare the letter and have it routed for comments prior to sending.
 
Dr. Morris requested the review team complete their reviews and obtain final signatures by close of business (COB) January 15, 2010, so that the CR letter could be completed and sent for final review prior to issue. Dr. Morris indicated the next monthly meeting would be held vial email. Ms. Wieland agreed to prepare minutes for this meeting.
 
 
Holly Wieland, RN, MPH
Regulatory Project Manager
FDA/CBER/OVRR
November 17, 2009