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Vaccines, Blood & Biologics

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No PREA Email, June 30, 2010 - Isoplate Solution

 

From: Simak, Jan

Sent: Wednesday, June 30, 2010 9:04 AM

To: Valencia, Iliana

Subject: FW: BN090067 PREA?

Iliana,

PREA will not be triggered for BN090067. I'll include justification in Summary Basis of Regulatory Action later in the review process. Thanks, jan

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From: Jain, Nisha

Sent: Tuesday, June 29, 2010 5:59 PM

To: Simak, Jan

Subject: RE: BN090067 PREA?

Yes , PREA is not triggered.

nisha

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From: Simak, Jan

Sent: Tuesday, June 29, 2010 5:13 PM

To: Jain, Nisha

Subject: FW: BN090067 PREA?

Hi Nisha,

we have a new NDA BN090067 Platelet Additive Solution B.Braun and in the filing memo I have to address the PREA issue. Do you agree that I'll refer to previous platelet additive solution NDA BN080041 where it was determined that PREA does not apply. Please let me know.

Thanks, Jan

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From: Haddad, Salim A

Sent: Tuesday, June 29, 2010 3:34 PM

To: Simak, Jan

Subject: RE: BN090067 PREA?

Jan,

Nisha Jain is the official in OBRR in charge of determining whether PREA applies or not. For my submission, the BN080041, she determined that it did not. In the attached SBRA-Summary Basis of Regulatory Action (top of page 8) she drafted the justification why PREA does not apply.

Attached is also an e-mail from Alan Williams/Bob Yetter explaining how PREA would not be triggered by platelet additive solutions.

Let me know if you have other questions on this submission.

Salim

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From: Simak, Jan

Sent: Tuesday, June 29, 2010 3:10 PM

To: Haddad, Salim A

Subject: FW: BN090067 PREA?

Hi Salim,

how did you handle PRE in your PAS NDA? I did not find any filing memo in the EDR for BN080041. Do you have any by chance. Thanks a lot, jan

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From: Valencia, Iliana

Sent: Tuesday, June 29, 2010 1:31 PM

To: Simak, Jan

Subject: BN090067 PREA?

Hi Jan,

At the filing meeting, I will need a filing memo from you. In this memo, please address the following:

1)       Does this submission trigger PREA?

2)       Is the sponsor waiver appropriate?

3)       Do you grant them the waiver request or not?

4)       If you do not, what is your proposed alternative?

I will then share this with Nisha and she will be able to set up the meeting for us if needed.

Thank you.

Iliana

___________

Iliana Valencia

Regulatory Project Manager

U.S. Food and Drug Administration

Center for Biologics Evaluation and Research (CBER)

WOC1; RM559N

1401 Rockville Pike

Rockville, MD 20852

Telephone: 301.827.6161

Fax: 301.827.2857

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