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Vaccines

Record of Telephone Conversation - May 20, 2009-2 - Prevnar 13

System Info - 94891  SMITH, MICHAEL J  22-May-2009 15:40:26  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.          

Telecon Date/Time:  20-MAY-2009 02:00 PM              Initiated by FDA?  Yes
Telephone Number:  845-602-1283

Communication Categorie(s):
1. Advice
2. Information Request

Author:  MICHAEL SMITH

Telecon Summary:
CBER informed Wyeth that Prevnar 13 is scheduled to go to the September VRBPAC

FDA Participants:   Julie Vallancourt, Mike Smith

Non-FDA Participants:    Jack Love

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
This telecon describes the phone conversation on May 20th and the additional communications with Jack over the next two days regarding the telecon.

Julie informed Jack that Prevnar 13 will go to the September VRBPAC, with a tentative date of SEPT 10.  Jack said he and Carmel Devlin would be Wyeth’s primary and secondary POCs for the BLA respectively. 

I requested the lot release protocol template for the BLA, as Karen Campbell said DMPQ needs it ahead of when the samples arrive at CBER.  Jack sent me the template as a PDF at 4:38 on May 20, 2009 and I forwarded it to Karen Campbell on the same day.  This template will also be included in a forthcoming amendment.

Jack said the CBER forms for the samples and reagents will probably be sent form two locations, the samples in the syringes will come from Pearl River, NY, while the conjugates will come from –(b)(4)---.

Jack also said he would contact Julie or I when the samples are shipped-this is expected to happen next Tuesday, May 26, 2009.

Jack said during the telecon that the remaining documents that Rajesh requested on April 30, 2009 (items C and D) are expected to be submitted to GlobalSubmit next Wednesday.  I told Jack that Rajesh needs to evaluate these documents to determine if there are any deficiencies, Jack suggested that perhaps these could also be emailed to Rajesh ahead of next Wednesday.  I asked Rajesh about this, and Rajesh suggested on Thursday that these documents be sent to him by overnight delivery on a CD or two.  Two CD’s were received by Rajesh today, Friday, May 22, 2009.  Jack also called me today and told me there were three additional documents that were inadvertently left out and he emailed those to Rajesh and I today at 12:14 PM.  These documents will also be submitted as an amendment in the future.  Additionally, Jack informed me today that these documents  will take longer to submit to GlobalSubmit than the initially expected May 27th date-and probably will not be submitted before Friday, May 29, 2009.  I then reminded jack that Rajesh needs to evaluate these documents for deficiencies and these potential deficiencies need to be sent out in a letter by June 13. 2009.  Jack understood and he said all the information contained in the documents to be submitted as an amendment is also contained either on the two CD’s or the three PDF’s received by Rajesh and myself at 12:14 PM on May 22, 1009.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448