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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation - TachoSil, March 11, 2010

(System Info - 122590 HE JIE 03/11/2010 08:47:59 HEJ)

RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA    Submission ID: 125351/0    Office: OBRR

Product:
Fibrin Sealant Patch

Applicant:
Nycomed Danmark ApS

Telecon Date/Time: 10-Mar-2010 02:10 PM        Initiated by FDA? Yes

Telephone Number: 1-919-456-4746

Communication Categorie(s):
1. Information Request

Author: JIE HE

Telecon Summary:
To request a pediatric deferral plan to study use of TachoSil in pediatric patients undergoing cardiovascular surgery

FDA Participants:

Kimberly Lindsey, MD
Jie He

Non-FDA Participants:
Carrie Langlais, PhD.
Trans-BLA Group: No

Related STNs: None
Related PMCs: None

Telecon Body:
Nycomed is requested to provide a pediatric deferral plan to study use of TachoSil in pediatric patients undergoing cardiovascular surgery and an overall plan for obtaining a general adjunct to hemostasis indication in pediatrics. Nycomed should also include how they intend to extrapolate the information in the adult studies to the pediatric studies since the safety numbers for pediatrics will be small. Response is expected by COB March 15, 2010.
Nycomed is also informed about additional change in the response the Agency has just received for the PI.