7/6/2007 Telecon - XYNTHA
Telecon with Wyeth
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
- 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.