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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 19, 2013, Approval Letter - Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal)

Our STN:  BL 125439/0

DIAGAST
Attention:  Ms. Marcia Palma
c/o NAMSA
4050 Olson Memorial Highway, Suite 450
Minneapolis, MN  55422

Dear Ms. Palma:

We have approved your biologics license application for Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Further Manufacturing Use) effective this date.   You are hereby authorized to introduce or deliver for introduction into interstate commerce, Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Further Manufacturing Use) under your existing Department of Health and Human Services U.S. License No. 1744.  Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Further Manufacturing Use) is indicated for use in the production of DG Gel® 8 Anti-IgG (Rabbit) and DG Gel ® 8 T/S Mono gel cards manufactured by Diagnostic Grifols, S.A., U.S. License No. 1887.

Under this authorization, you are approved to manufacture Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Further Manufacturing Use) at your facility in Loos, France.  You must label your product with the proper name Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Further Manufacturing Use) that we have approved, and market it as approved in your license application.

We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

The dating period for Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Further Manufacturing Use) shall be 24 months from the date of manufacture when stored at 2-8 ºC.  The date of manufacture shall be defined as the date of the final ------(b)(4)------ prior to the filling operation. 

You currently are not required to submit samples of future lots of Anti-Human Globulin, Anti-IgG (Rabbit Polyclonal) (For Further Manufacturing Use) to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2.  We will continue to monitor compliance with 21 CFR 610.1 requiring completion of tests for conformity with standards applicable to the product prior to release of each lot.

Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with a Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.

ADVERSE EVENT REPORTING

You must submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by 21 CFR 600.80(k)(2).  Since your product is characterized as a device as well as a biological, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A. Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, P.O. Box 3002, Rockville, Maryland 20847-3002.

AGREED UPON POSTMARKETING COMMITMENTS

We acknowledge your written commitments as described in your letter of April 8, 2013, and as outlined below:

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.  

  1. DIAGAST commits to perform a retrospective validation to establish a -------------------------(b)(4)-----------------------------. This will include data from the conformance lots and a review of non-U.S. Anti-IgG lots manufactured using an identical process, specifications, and acceptance criteria as the process described in the current BLA.  DIAGAST will submit the results to FDA as a Postmarketing Study Commitment – Final Study Report by September 5, 2013.
  1. DIAGAST commits to perform a retrospective validation to establish a -------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------.  This will include data from the conformance lots and a review of non-U.S. Anti-IgG lots manufactured using an identical process, specifications, and acceptance criteria as the process described in the current BLA.  DIAGAST will submit the results to FDA as a Postmarketing Study Commitment – Final Study Report by September 5, 2013.
  1. DIAGAST commits to perform a revalidation of the --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- will be established based on trend results according to this method.  DIAGAST will submit the results to FDA as a Postmarketing Study Commitment – Final Study Report by September 5, 2013.
  1. DIAGAST commits to perform an -----------------------------(b)(4)-------------------------- for the Anti-IgG product to show the effectiveness of ----------------------------------(b)(4)----------------------------------- is not diminished or inhibited by the product.  DIAGAST will submit the results to FDA as a Postmarketing Study Commitment – Final Study Report by September 5, 2013.

We request that you submit information concerning nonclinical and chemistry, manufacturing, and control postmarketing commitments and final reports to your BLA, STN BL 125439/0.

Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:

  • Postmarketing Study Correspondence
  • Postmarketing Study Commitment – Final Study Report
  • Supplement Contains Postmarketing Study Commitment – Final Study Report

For each postmarketing commitment not subject to the reporting requirements of 21 CFR 601.70, you may report the status to FDA as a “PMC Submission – Status Update.”  The status report for each commitment should include:

  • The original schedule for the commitment, and
  • The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).

When you have fulfilled your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.

Sincerely yours,

Jay S. Epstein, MD
Director
Office of Blood Research and Review
Center for Biologics
Evaluation and Research