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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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7/6/2007 Telecon - XYNTHA

Telecon with Wyeth

6-July-2007

RE: STN: 125264/0
Deficiencies Identify Call

Meeting called by:
Franklin. Stephenson/ RPM

Type of meeting: Telecon

FDA Participants: Franklin Stephenson, Pauline Cottrell, Dr. Timothy Lee

Wyeth Participants: Joyce Schwenk

Agenda

Conversation Record:

  • We placed a call to Wyeth to let them know the current status of the review. We informed than that so far there were no deficiencies identified. We inquired if the conformance lots and release protocols were sent to the Product Release Branch. Ms Schwenk informed us that she will check with her staff on the status of the lots and protocol.
  • We explained to her that this call was made as part of PDUFA requirements.
  • The conversation ended cordially.