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Record of Telephone Conversation, May 8, 2009 - Adenovirus
Submission Type: Original Application Submission ID: 125296/0 Office: OVRR
Adenovirus Vaccine Live Oral Type 4 and Type 7
Duramed Research Inc.
Telecon Date/Time: 08-MAY-2009 03:40 PM Initiated by FDA? Yes
Telephone Number: 610-747-2664
Author: DARYLL MILLER
Providing information about the PI
FDA Participants: Daryll Miller
Non-FDA Participants: John Pakulski
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
A message was left on John Pakulski’s office telephone regarding the PI. We expect to send our first version of the PI by the end of next week (May 15). Called to let them know that we plan to give the product a Pregnancy Category D due to a literature search which found some articles where Adenovirus was discovered in adverse pregnancy outcomes. We will speak with him next week regarding this issue.