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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, May 8, 2009 - Adenovirus 

Submission Type: Original Application   Submission ID:  125296/0    Office: OVRR  

Product:
Adenovirus Vaccine Live Oral Type 4 and Type 7

Applicant:                                                                       
Duramed Research Inc.          

Telecon Date/Time:  08-MAY-2009 03:40 PM                Initiated by FDA?  Yes
Telephone Number:    610-747-2664

Communication Categorie(s):
Advice

Author:  DARYLL MILLER

Telecon Summary:
Providing information about the PI

FDA Participants:   Daryll Miller

Non-FDA Participants:  John Pakulski 

Trans-BLA Group: No

  
Related STNs:  None

Related PMCs:  None

Telecon Body:
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.