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Vaccines

Email Exchange between 1/22/2008 - 3/4/2008 - Rotarix

From: Watson, Anthony
Sent: Tuesday, March 04, 2008 10:37 PM
To: Syed, Sajjad H; Henchal, Laraine
Cc: Vujcic, Luba; OC Combination Products
Subject: RE: Final review fro Rotarix plastic tansfer device?

Having said all of that, it is your call as we are only consultants here. We do not require a signed copy as I see all of the reviews before they are sent out. If I am cc'd on the e-mail you receive, that is usually sufficient. Do you need a signed copy? Other groups have not required that in the past, but if you need it, we will get you one.

Anthony D. Watson, BS, MS, MBA
Chief, General Hospital Devices Branch
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Tel: (240) 276-3703
Fax: (240) 276-3789

_______________________________________________

 

From: Syed, Sajjad H
Sent: Tuesday, March 04, 2008 5:23 PM
To: Henchal, Laraine
Cc: Vujcic, Luba; Watson, Anthony
Subject: RE: Final review fro Rotarix plastic tansfer device?

Hey

The sponsor has not stated that the syringe -----------------. The sponsor is stating that the adaptor is not sterilized. After consulting with our medical officer, we believe that unsterilized adaptor (coming into contact with the vaccine and the patient) can be contaminated. Secondly, the sterilization data they have provided is unclear about what part of the system they have sterilized with what method. For example; at one point they stated that the -------------------------------------------------------------------, then they give us ------------ values which do not make any sense since -------------------------------------------- -------------. They need to clearly identify the device (plunger, syringe, stopper, adaptor) and the type of sterilization performed on it. I was asking for the biocompatibility to be performed on the final finished product (syringe, plunger and adapter), but I do see that they have purchased an adaptor that is ISO 10993-1 tested. So the sponsor does not need to perform the bio again.

Regards,

Sajjad

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From: Henchal, Laraine
Sent: Tuesday, March 04, 2008 4:23 PM
To: Syed, Sajjad H
Cc: Watson, Anthony; Vujcic, Luba
Subject: RE: Final review fro Rotarix plastic tansfer device?

Hi,

I am not exactly sure what the status of this review is. It is not signed. Do you folks have an electronic signature process? If you can sign a pdf document, I should be able to certify it from our side and put into our EDR with the Word version (unfortunately due to new FDAAA regs, I need both). Thanks, Let me know...

I verify in this e-mail that the instructions for use are included in the package insert, so it is not necessary for instructions to be directly included on the packaging for these oral delivery materials. Also as stated before , we do not believe it is a necessity for the transfer adaptor to be sterilzed. In addition, in regard to the necessity for the biocompatability tests: you state in your comments on the sponsor's Jan 22, 2008 response to question 1 that The adapter is compliant with requirements of ISO 10993-1 (biocompatibility tests for medical devices),--------------------------------------------------------------------------------- -------------------------------------------- I am not quite sure what else is needed for the adaptor. In addition, the company is performing potency testing of the vaccine when resuspended with the diluent that comes into contact with the glass syringe, so I am not sure that we (CBER) would require additional biocompatability testing to be done with this sterilized glass, ----------- syringe. Is the syringe 510k approved?

Laraine S. Henchal, MAS
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532

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From: Syed, Sajjad H
Sent: Monday, March 03, 2008 5:36 PM
To: Henchal, Laraine
Cc: Watson, Anthony
Subject: RE: Final review fro Rotarix plastic tansfer device?

Hey Laraine,

I have attached my updated memo below. Please let me know if you have any questions.

Regards,

Sajjad

<< File: CON076106_BLA125265_Response1.doc >>

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From: Henchal, Laraine
Sent: Monday, March 03, 2008 10:38 AM
To: Syed, Sajjad H
Cc: Vujcic, Luba
Subject: RE: Final review fro Rotarix plastic tansfer device?

Yes, I have just checked. I sent you their responses to your questions on Jan 15 and 22. Please updata your memo to reflect their responses to your original questions. Thanks, L

Laraine S. Henchal, MAS
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532

_______________________________________________

 

From: Syed, Sajjad H
Sent: Friday, February 29, 2008 6:21 PM
To: Henchal, Laraine
Subject: RE: Final review fro Rotarix plastic tansfer device?

Hi Laraine,

I have attached my memo below. Let me know if you have any questions or comments.

Regards,

Sajjad

<< File: CON076106_BLA125265.doc >>

_______________________________________________

 

From: Henchal, Laraine
Sent: Friday, February 29, 2008 5:59 PM
To: Syed, Sajjad H
Cc: Vujcic, Luba
Subject: Final review fro Rotarix plastic tansfer device?

We are going to try and start putting the stuff together for the Rotarix file (BLA #125265/0). Do you have your review done? Can you send in Word and a signed pdf? We can load them into our database if you send them to us...Thanks, Laraine Henchal

Laraine S. Henchal, MAS
Microbiologist Reviewer, Team Leader
Viral Vaccines Branch
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Phone: 301-827-3070
Fax: 301-827-3532

_______________________________________________

 

From: Syed, Sajjad H
Sent: Tuesday, January 22, 2008 11:14 AM
To: Henchal, Laraine
Subject: RE: Last response to your questions for Rotarix device-21jan2008.pdf

Hi Laraine,

I will review the info and let you know.

Regards,

Sajjad

_______________________________________________

 

From: Henchal, Laraine
Sent: Tuesday, January 22, 2008 11:12 AM
To: Syed, Sajjad H
Cc: Vujcic, Luba
Subject: Last response to your questions for Rotarix device-21jan2008.pdf

<< File: quality-21jan2008.pdf >>

Hi Sajjad,

Repsonse from GSK to your last question. Laraine

 

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