Resubmission Acknowledgement Email, September 26, 2012 - EVARREST

Tilghman, Tracy

 

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From:         Lindsey, Kimberly

 

Sent:          Wednesday, September 26, 2012 4:33 PM

To:             Tilghman, Tracy

Cc:             Ananyeva, Natalya

Subject:     RE: Resubmission Acknowledgement for STN 125392 - Please respond by COB 10- Apr-12

 

Hi Tracy,

The justification is in the draft SBRA. Natalya can also comment, as she may have a memo. Here it is:

OBRR reviewed information from this application and determined that referral to the Blood Products Advisory Committee (BPAC) prior to licensure is not needed for the following reasons (FDAAA [HR 3580-138 SEC. 918: REFERRAL TO ADVISORY COMMITTEE]):

 

1.  New molecular entity provision (NME) does not apply to EVARREST as it does not represent a historically novel product class. Fibrin sealants have been used as an adjunct to hemostasis since the late 1970’s in Europe and since 1998 in the United States (TISSEEL manufactured by Baxter was approved by FDA in May 1998).

 

2.   The mechanism of action of fibrin sealants (fibrinogen/thrombin products) and their function in blood coagulation and control of local hemorrhage is well studied and understood. Upon contact with the bleeding wound surface, the fibrinogen-thrombin reaction initiates the last step of the coagulation cascade – formation of a fibrin clot.

 

3.   The Biological Components of EVARREST are ---b(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Both components of the Backing layer -----------------------------------------------------------b(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

4.   A similar combination fibrin sealant product TachoSil (Takeda

Pharmaceuticals / Nycomed) has been used in European Union since

2004 and was approved by FDA in 2010 (STN 125351) as an adjunct to hemostasis in cardiovascular surgery where standard techniques are insufficient.

 

5.   The overall clinical program to evaluate efficacy and safety of EVARREST

was adequate and did not raise any major concerns.

 

6.   Review of information submitted in the BLA for EVARREST did not raise any controversial issues or pose unanswered scientific questions which

 

would have benefited from advisory committee discussion and recommendation.

 

 

 

Thanks, Kimberly

 

From:                     Tilghman, Tracy

Sent:                      Wednesday, September 26, 2012 4:29 PM

To:                          Lindsey, Kimberly

Cc:                          Ananyeva, Natalya

Subject:                FW: Resubmission Acknowledgement for STN 125392 - Please respond by COB 10-Apr-12

 

Hi Kimberly,

 

Do you have a justification memo regarding why this submission did not have to go to an

Advisory committee? It’s needed for the LARM. Thanks,

Tracy

301-827-9427 tracy.tilghman@fda.hhs.gov

 

 

From: Lindsey, Kimberly

Sent: Monday, April 09, 2012 12:28 PM

To: Tilghman, Tracy; Jain, Nisha

Cc: Ananyeva, Natalya; Shields, Mark

Subject: RE: Resubmission Acknowledgement for STN 125392 - Please respond by COB 10-Apr-

12

 

Tracy,

Natalya, is the chair and I will defer to her to respond to the general questions once she seeks input from all review disciplines.

 

As for the clinical:

 

1. Does this resubmission warrant an Advisory Committee review? If so, please list pertinent advisory committee information or provide justification   otherwise.

I do not anticipate that an advisory committee review will be necessary.

 

2. Does this resubmission warrant PREA?

This submission does trigger a PREA review.

 

3. Do you continue to require a CDRH consult or like to keep the current CDRH consult on this file? If so, please let me know. A consult request was previously generated that can be modified for the resubmission.

Please retain the current CDRH consultants for continuity. I can assist preparing in the consult request for Roxi Horbowyj.

 

Kimberly

 

From:                     Tilghman, Tracy

Sent:                      Friday, April 06, 2012 1:20 PM

To:                          Lindsey, Kimberly

Cc:                          Ananyeva, Natalya; Shields, Mark

Subject:                Resubmission Acknowledgement for STN 125392 - Please respond by COB 10-Apr-12

Importance:        High

 

Hello Kimberly,

 

We have received the response to the CR letter for STN#125392 dated 19 September

2011. Currently this is being considered a Class 2 resubmission, which can potentially restart the clock and PDUFA deadlines for this submission. At this time, please provide the following information:

 

1. Please indicate whether this submission is sufficient to be considered a Complete

Response and to warrant the restart of the review clock.

2. Please provide your assessment of the Class of the resubmission. Additionally, please provide a response to the following:

Clinical

1. Does this resubmission warrant an Advisory Committee review? If so, please list pertinent advisory committee information or provide justification   otherwise.

2. Does this resubmission warrant PREA?

3. Do you continue to require a CDRH consult or like to keep the current CDRH consult on this file? If so, please let me know. A consult request was previously generated that can be modified for the resubmission.

 

Please note that the review of the response to the CR letter is on a time clock.  Please submit your response to me via email by close of business on Tuesday, April 10, 2012. If you foresee any difficulty with adhering to this deadline, please let me know at your earliest possible convenience.

 

The links to the pertinent SOPP and access to the resubmission are provided below:

 

SOPP link: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformatio n/ProceduresSOPPs/ucm073490.htm

 

Access to resubmission:

This is an eCTD submission.  Select the link to access the .enx file:

----b(4)----------------------------------------------------------------------------

 

STN#: 125392

Product: Fibrin Pad

 

Short Summary: Fibrin Pad is as an adjunct to hemostasis for soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, and (non-cardiac) thoracic surgery when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical

 

Thanks,

 

Tracy Tilghman, MPH

Lieutenant, United States Public Health Service

Regulatory Project Manager

U.S. Food & Drug Administration CBER/OBRR/DBA/RPMB WOC1, RM 556N, HFM-380

Rockville, MD 20852

Phone: 301-827-9427

Email: tracy.tilghman@fda.hhs.gov

 

 

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