Memorandum, June 16, 2011 - Spherusol
Date: June 16, 2011
To: H.S. Nielsen, Jr., Ph.D.
Allermed Laboratories, Inc
7203 Convoy Court
San Diego, CA 92111
Our review of your Biologics License Application (BLA) for Spherusol Skin Test Antigen, STN 125354/0, is ongoing. We have the following additional comments relating to the Debarment Certificate contained within your May 26, 2009 original BLA submission and your proposed Pharmacovigilance Plan, contained within the October 15, 2009 submission to your BLA:
The following item pertains to the Debarment Certificate:
1. Please revise your Debarment Certificate such that it is not limited to specific individuals and does not include the use of conditional or qualifying language, such as to the best of my knowledge. Please note that the use of such language is considered to be unsatisfactory.In this regard, the following wording is the most acceptable form of certification:
“[Name of Applicant] hereby certifies that it did not and will not use in any capacity the services of any person debarred under section 306 of the Federal Food, Drug, and Cosmetic Act in connection with this application.”
The following items pertain to your proposed Pharmacovigilance Plan:
2. Please monitor and report AEs, including submissions of 15-day reports for serious, unlabeled AEs and PAERs, quarterly for the first three years of licensure and yearly thereafter, as required under 21 CFR 600.80.
3. Regarding your proposed post-market survey, please consider specifically analyzing and reporting survey data on -----------------------------------(b)(4)---------------------------------.
4. Please consider the following suggestions for improvements to the proposed survey form:
a. Item # 1 should specify date of report and not date of administration;
b. Item #6 should request a response regarding the method for diagnosing coccidiomycosis, the date of diagnosis, and the treatment only if the response to the first part of the question (subject diagnosed with coccdiomycosis?) is yes;
c. The form could ask for concomitant medications;
d. The form could allow for physicians to add serious adverse events not included on the pre- specified list.
We request that you submit the above information as soon as possible, but preferably before June 23, 2011.
If you have any questions regarding the above comments, please contact either Ms. Holly Wieland or Dr. Jon Daugherty at 301-796-2640.