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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Mid-Cycle Meeting Summary - RiaSTAP

MEMORANDUM

Date:

16 October 2008        Time: 10:30 PM – 11:30 AM

From:

Vasantha Kumar

To:

STN 125317/0

Subject:

 CSLB’s Human Fibrinogen Concentrate (RiaSTAP)

 CBER Participants:

Vasantha Kumar
Laura Wood
Nisha jain
Roman Drews
La’Nissa Brown
Boris Zaslavsky
Rebecca Olin
Loan Nguyen
Christine Drabick
Iftekhar Mahmood
Craig Zinderman Tim Lee Lisa Stockbridge Faith Barash Nannette Cagungun

Background:

On 18 July 2008, FDA received the Original BLA submission and the reviewers were assigned and after a preliminary review, a First Committee meeting was held followed by a Filing meeting. The submission was found fileable.

The mid cycle meeting was held to discuss the level of completion of review with reference to labeling, BIMO nspecton, Lot Release Testing Plans, Post Marketing safety studies and BPAC preparations.

 Discussion:

Most of the reviewers had submitted their mid-cycle memos. The following comments were the highlights:

  • The clinical reviewer wanted an acknowledgement that the study B13203_3001 was a PMR and requested CSLB to submit the real time tracing obtained from TEG that were used for MCF calculations.
  • APLB had considerd the proposed proprietary name RIASTAP and conclude that under 21 CFR Part 201 the proposed proprietary name is acceptable with concerns at this time. Using tall-man lettering (i.e. RIAstaP) is recommended to mitigate potential risk of medication errors with currently marketed products.
  • BIMO Inspection assignments were issued to three clinical sites. The inspections at two of the sites have been completed and the third one is still pending.
  • The pharmacokinetic study design and analysis of Haemocomplettan P was found to be acceptable. However, the sponsor should incorporate the clinical pharmacology labeling of Haemocomplettan P as suggested by the FDA.
  • CMC reviewers Roman Drew and Ze Peng had information requests to be sent to CSLB
  • APLB reviewer Loan Nguyen had labeling questions and OBE reviewer Craig Zindermann requested a pharmacovigilance plan to be submitted.

Lot release plan has been prepared and will be sent to Debbie Jansen. Conformance Lot Release Testing has been requested for moisture, appearance, solubility, pH, sterlity ans -(b)(4)-. The results are not available yet. The first draft of the press release is being written.