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Vaccines, Blood & Biologics

Record of Telephone Conversation, August 23, 2012 PM- EVARREST


Submission Type: BLA    Submission ID: 125392/0    Office: OBRR


Fibrin Sealant Patch [EVARREST]


Ethicon Inc.

Telecon Date/Time: 23 August 2012              2:00 P.M.        Initiated by FDA?   No

Telephone Number: ---b(4)---------, Participant Code: --b(4)-----------

Communication Categorie(s):

1. Other – Clarification on Lot Release process


Telecon Summary:

Discussion of Lot Release process and currently available lots of EVARREST

FDA Participants:

Natalya Ananyeva

Tracy Tilghman


Non-FDA Participants (Ethicon, Inc.):

Jessica Chung



Trans-BLA Group: No

Related STNs: None

Related PMCs: None


Telecon Body:

Ethicon Inc. (Ethicon) requested clarification on the Lot/Batch Release process. Specifically, Ethicon inquired whether the completed Lot Release Protocols and the samples must be provided to the FDA prior to PDUFA Action Due Date or may be submitted post-approval of the BLA.


FDA stated that detailed instructions on the Lot Release process for the licensing action for EVARREST were earlier provided to Ethicon during two teleconferences (June 13th and June 27th, 2012). FDA clarified that after the agreed-upon version of Lot Release Protocol template has been developed, Ethicon must send the completed protocols and the samples of three lots to the Product Release Branch for review. These lots must be representative of the manufacturing process at the commercial scale, be within the dating period, and intended for commercial distribution. Lot Release process for the licensing action is part of the BLA review and must be completed concurrently with the regulatory action for the BLA (PDUFA Action Due Date).


Ethicon confirmed that the Lot Release process was outlined by the FDA earlier. Ethicon stated that at this time they have –b(4)- representative –b(4)-with –b(4)-- samples and the protocol available for submission, another batch that has recently expired so that only the protocol can be submitted (i.e. without samples), and the –b(4)---- will be manufactured and available for submission in September 2012. Ethicon inquired how this situation can be handled.


FDA stated that the Product Office will need to consult with the Product Release Branch. FDA indicated that one potential option would be extension of the review clock for a major amendment to allow additional time for the company to submit the necessary product lots for the licensing action.


Ethicon emphasized that they would like to avoid extending the review clock and suggested that –b(4)-----------------------------------------------------. FDA re-stated that they will consult with the Product Release Branch and provide instructions to Ethicon as a formal Information Request. 



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