
Record of Telephone Conversation, January 9, 2013 - Flublok

 
 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 09-Jan-2013 05:18 PM        Initiated by FDA? Yes

Telephone Number: Communicated via e-mail

Communication Categorie(s):

1. Advice

Author: TIMOTHY FRITZ

Telecon Summary:

Removal of CBER requested PMC

FDA Participants: Timothy Fritz

Non-FDA Participants: Penny Post

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

From:                    Fritz, Timothy

Sent:                      Wednesday, January 09, 2013 5:18 PM

To:                         'Penny Post'

Subject:                 CBER recommendation for Flublok PMRs/PMCs

 

Importance:           High

Dear Dr. Post-

 

In our e-mail sent on December 13, 2012, we requested that Protein Sciences Corporation (PSC) commit to providing the results of a pediatric efficacy study that may be conducted in the European Union as a PMC for Flublok approval. Following additional internal discussion, we have decided to remove this PMC from the Flublok approval. Therefore, you may remove this PMC from your response to our request for an updated PMR/PMC commitment letter sent via e-mail on the morning of January 9, 2013.

 

If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640.

 

Thank you.

Timothy A. Fritz, Ph.D. 
Microbiologist 
FDA/CBER/OVRR/DVRPA/CMC2 
WOC2 HFM-478
1451 Rockville Pike 
Rockville, MD 20852 
Phone: 301-796-2640 
Fax: 301-827-1597

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