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Record of Telephone Conversation - TachoSil, February 23, 2010

System Info - 120864 HE, JIE 23-Feb-2010 09:43:43 HEJ

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application Submission ID: 125351/0 Office: OBRR

Product:
Fibrin Sealant Patch

Applicant:
Nycomed Danmark ApS

Telecon Date/Time: 22-FEB-2010 12:00 AM Initiated by FDA? Yes
Telephone Number: 919-456-4746

Communication Categorie(s):
Information Request

Author: JIE HE

Telecon Summary:
IR regarding Pediatric study plan

FDA Participants:
Jie he

Non-FDA Participants:
Carrie Langlais

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Dear Dr. Langlais:

We are reaching the late stage of the review for your BLA. There are questions regarding the pediatric study that needs immediate response from Nycomed.
The Pediatric Plan submitted for deferrals MUST include a brief description of studies in addition to:

Date of protocol submission

Date of study completion

Date of study report submission

Please submit this information to us ASAP.

Kind regards,

Jie He
Regulatory Project Manager
U.S. Food & Drug Administration
CBER/ OBRR/ DBA/ RPMB
WOC1; RM554N; HFM-380
301-827-9167 fax 301-827-2857
email: jie.he@fda.hhs.gov