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Vaccines, Blood & Biologics

Record of Telephone Conversation, November 30, 2012 - Flublok


Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Influenza Vaccine
Protein Sciences Corporation
Telecon Date/Time: 30-Nov-2012 02:49 PM        Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
Communication Categorie(s):
1. Advice
Telecon Summary:
Potential list of postmarketing studies.
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post, Manon Cox
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
From:                    Fritz, Timothy
Sent:                      Friday, November 30, 2012 2:49 PM
To:                         'Penny Post'
Cc:                         Manon Cox
Subject:                 Potential postmarketing studies for STN 125285 (Flublok)
Importance:           High
Dear Dr. Post-
We are currently determining the postmarketing requirements/commitments that will be associated with the Flublok BLA (STN 125285) and want to inform Protein Sciences Corporation (PSC) of the studies being considered for your planning purposes. It is important to note that the following list is preliminary and may be incomplete and that we have not reached a final determination for the studies to be conducted. Please also note that, for the final study list agreed upon between CBER and PSC, PSC will need to provide dates for study protocol submission, study initiation and completion and final study report submission.
Postmarketing Requirements
1. Deferred pediatric study under PREA to evaluate the safety, reactogenicity and immunogenicity of Flublok in children 6-17 years of age.
2. Deferred pediatric study under PREA to evaluate the safety, reactogenicity and immunogenicity of Flublok in healthy children 3-5 years of age.
Postmarketing Commitments
3. Large, Phase 4 observational safety and immunogenicity study (PSC07/09) in adults 18-49 years old.
4. Establishment of a Flublok pregnancy registry.
If you have any questions, please contact the Regulatory Project Chair, Dr. Timothy Fritz, at 301-796-2640.
Thank you.
Timothy A. Fritz, Ph.D.
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
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