
Record of Telephone Conversation, April 4, 2012 - MenHibrix

 

 
(System Info - 195779 STATEN DAVID 04/04/2012 14:56:29 STATEND)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA    Submission ID: 125347/152    Office: OVRR

Product:
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Applicant:
GlaxoSmithKline Biologicals
Telecon Date/Time: 04-Apr-2012 10:10 AM        Initiated by FDA? Yes
Telephone Number: ----(b)(4)-----

Communication Categorie(s):
1. Labeling via FAX/e-mail

Author: DAVID STATEN
Telecon Summary:
FDA requested that the statement, ¿Use a separate sterile needle and sterile syringe for each individual¿ to the PI.  GSK agreed
FDA Participants: None

Non-FDA Participants: None
 

Trans-BLA Group: No

Related STNs: None Related PMCs: None Telecon Body:
 

 
[Enter details of telecon here