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Excursion Discussion Email, August 2, 2011 - Anascorp

From: Fisher, Robert
Sent: Tuesday, August 02, 2011 1:00 PM
To: Epstein, Jay; Scott, Dorothy
Cc: Cordaro, Debbie; Farshid, Mahmood
Subject: RE: Temperature excursions for Anascorp

I think that would be a very good compromise.  Thank you for the suggestion!


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From: Epstein, Jay
Sent: Tuesday, August 02, 2011 12:51
To: Scott, Dorothy
Cc: Fisher, Robert; Cordaro, Debbie; Farshid, Mahmood
Subject: RE: Temperature excursions for Anascorp


What if the approval letter were to say "brief temperature excursions..."  This would not require a change to product labeling, which could be clarified later when time permits.

 

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From: Scott, Dorothy
Sent: Tuesday, August 02, 2011 12:08 PM
To: Epstein, Jay
Cc: Fisher, Robert; Cordaro, Debbie; Farshid, Mahmood
Subject: Temperature excursions for Anascorp


Hi Jay,

    The study that was done at 40 degrees C was for the first 6 months of the dating period after manufacturing, and would cover typical short-term excursions.  We are reluctant to specify 6 months the stability data does not represent worst case, which would be (b)(4) degrees C in the last 6 months of the dating period.   

We do feel the data we have shows Anascorp to be a very stable product, so that typical excursions occuring during shipping or emergency use in remote rural areas in the hot climate of the desert Southwest will be o.k.    We would like to convey this message, and it is consistent with USP-style labeling. 

ICH Q1A (R2) states that accelerated stability studies can be used to assess short term temperature excursions:  "Data from the accelerated storage condition and, if appropriate, from the intermediate storage condition can be used to evaluate the effect of short term excursions outside the label storage conditions (such as might occur during shipping)."
We have interpreted "excursions" to mean unintentional exposure to temperatures higher than the those of routine storage conditions, and expect these would be short term.  

A secondary logistical concern is that we will have to change and get Robert's memo re-signed, contact APLB, and contact the company to change the PI and time is running out.

Thanks,

Dot 


  

 

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From: Epstein, Jay
Sent: Tuesday, August 02, 2011 10:54 AM
To: Cordaro, Debbie
Cc: Scott, Dorothy; Fisher, Robert
Subject: FW: Anascorp documents and update on the status of the concerns.


Debbie,

I have one comment on the draft approval letter (see attachment).  In this regard, please ask DH to clarify how the dating period is affected by temperature excursions.  In particular, what is the maximum duration of excursions to 40C for a dating period of two years?  (The stability data looked at exposure to 40C out to six months.)  The current approval places no restriction on excursions.

Jay

 

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From: Cordaro, Debbie
Sent: Tuesday, August 02, 2011 10:29 AM
To: Epstein, Jay
Subject: Anascorp documents and update on the status of the concerns.


Hi Jay,

This review changes by the minute.  Below is the link to RDT file documents.  The SBRA is ready for your signature. 
http://eroom.fda.gov/eRoom/CBER/CBER-OBRAR/0_385a1

The Word version of the current approval letter (lacking the new PMCs) is attached for your review.

Debbie


Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR
Voice: 301-827-6157
debbie.cordaro@fda.hhs.gov

 

 

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From: Scott, Dorothy
Sent: Tuesday, August 02, 2011 10:23 AM
To: Eltermann, John; Fisher, Robert; Trout, Deborah; Cordaro, Debbie; Ertel, Donald
Cc: Waites, Nancy; Farshid, Mahmood
Subject: RE: Information Request


I can't tell you what an enormous relief this is.

 

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From: Eltermann, John
Sent: Tuesday, August 02, 2011 10:14 AM
To: Fisher, Robert; Trout, Deborah; Cordaro, Debbie; Ertel, Donald
Cc: Waites, Nancy; Scott, Dorothy; Farshid, Mahmood
Subject: RE: Information Request


We have gotten the word from DCM that based on the information we have on the lyophilizer ---(b)(4)-- we can go forward with the approval.  Having said that, there are still some PMC issues that are being worked out as noted below.  However, the major issue seems to have been resolved.

Jay

 

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From: Fisher, Robert
Sent: Tuesday, August 02, 2011 10:02 AM
To: Trout, Deborah; Cordaro, Debbie; Ertel, Donald
Cc: Waites, Nancy; Eltermann, John; Scott, Dorothy; Farshid, Mahmood
Subject: RE: Information Request


Please let me know if there's anything I can do to facilitate progress.  Our Office Director is only available to sign today; tomorrow is the ADD.

 

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From: Trout, Deborah
Sent: Tuesday, August 02, 2011 10:00
To: Cordaro, Debbie; Ertel, Donald
Cc: Waites, Nancy; Fisher, Robert; Eltermann, John
Subject: RE: Information Request


Sorry for the delay but there are concerns with the lyophilizer --------------------(b)(4)-------------------, we have asked DCM to weigh in on its acceptability.

I'm also concerned with the method validation associated lyophilizer cleaning , it's critical that the firm demonstrate -----------------------------------------------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------. We will ask for a PMC.

In addition, we still need to clarify issues associated with the sterile bulk.

Hopefully everything will be resolved today.

 

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From: Cordaro, Debbie
Sent: Tuesday, August 02, 2011 9:42 AM
To: Ertel, Donald
Cc: Waites, Nancy; Fisher, Robert; Trout, Deborah
Subject: RE: Information Request


I know I am going to be asked, can you give me a general time estimate when you might know...before lunch, after lunch...?  The Office director is going to be on-site waiting to sign, and I would like to give him some time estimate, if possible.

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR
Voice: 301-827-6157
debbie.cordaro@fda.hhs.gov

 

 

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From: Ertel, Donald
Sent: Tuesday, August 02, 2011 9:32 AM
To: Cordaro, Debbie
Cc: Waites, Nancy; Fisher, Robert; Trout, Deborah
Subject: RE: Information Request


We are working on it…

__________________________________________________________________________________
__________________________________________________________________________________

Donald Ertel
Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ
1401 Rockville Pike, HFM-675
Rockville, MD  20852-1448
Office: 301.827.7121
Fax: 301.827.3536


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From: Cordaro, Debbie
Sent: Tuesday, August 02, 2011 8:09 AM
To: Ertel, Donald
Cc: Waites, Nancy; Fisher, Robert; Trout, Deborah
Subject: RE: Information Request

 

Hi Don,

 

Have you made a determination of the acceptability of their responses?  How will you document your assessment?  I forwarded their email with the responses to DCC for uploading as an official amendment.

 

Debbie

 

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR
Voice: 301-827-6157
debbie.cordaro@fda.hhs.gov

 

 


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From: Ertel, Donald
Sent: Monday, August 01, 2011 8:44 PM
To: 'Jennifer Spinella'
Cc: Waites, Nancy; Fisher, Robert; Trout, Deborah; ---(b)(4)---; Cordaro, Debbie
Subject: RE: Information Request

Jennifer,

 

thanks for the quick response.  Evaluating your responses…. I will call you or email you if I have further questions.

 

Don

 

__________________________________________________________________________________
__________________________________________________________________________________

Donald Ertel
Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ
1401 Rockville Pike, HFM-675
Rockville, MD  20852-1448
Office: 301.827.7121
Fax: 301.827.3536


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From: Jennifer Spinella [mailto:jspinella@raretx.com]
Sent: Monday, August 01, 2011 8:15 PM
To: Ertel, Donald; ---(b)(4)---; Cordaro, Debbie
Cc: Waites, Nancy; Fisher, Robert
Subject: RE: Information Request
Importance: High

 

Hi Donald and Debbie,

Attached please find our responses to the information request from today.  If you have any questions, please feel free to contact me directly.

Thank you,

Jennifer

 

Jennifer Spinella, MT(ASCP), RAC

Vice President, Regulatory Affairs & Quality Assurance

Rare Disease Therapeutics, Inc.

9550 Cuyamaca Street, Suite 203

Santee, CA 92071

Phone:  619-328-5370

Fax:  619-328-5379

email:  jspinella@raretx.com

 

 

 

From: Ertel, Donald [mailto:Donald.Ertel@fda.hhs.gov]
Sent: Monday, August 01, 2011 12:36 PM
To: Jennifer Spinella; ---(b)(4)---
Cc: Waites, Nancy; Fisher, Robert
Subject: Information Request

 

Jennifer and (b)(4),

 

I have an information request in support of the review of:

 

STN 125355/0

Anascorp®, Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection

 

  1.. Is an AQL sampling for visual inspection being performed for the final container (vial) after the 100% visual inspection and prior to release?  If so, what are your sample size and acceptance limits?
  2.. Have you performed bioburden log reduction studies for the ------------(b)(4)-------------- the lyophilizer?  If so, per what protocol and what was the log reduction required?
a.     What -----(b)(4)------ were studied? What contact time, temperature, and rinsing was required?

b.     How did you test for ----------(b)(4)----------, and what was the acceptance limit?

  3.. At what step in process is the sample taken for sterility testing for the Bulk? Is the sample taken directly from the bulk container?
 

I will follow-up with a phone call.

 

Don Ertel

 

__________________________________________________________________________________

__________________________________________________________________________________

 

Donald Ertel

Consumer Safety Officer

FDA/CBER/OCBQ/DMPQ

1401 Rockville Pike, HFM-675

Rockville, MD  20852-1448

Office: 301.827.7121

Fax: 301.827.3536