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Correction - February 29, 2012 Approval Letter - T.R.U.E. Test

 

Our STN: BL 103738/5074
 
June 15, 2012
 
Mekos Laboratories AS
Attention: Kim M. Sullivan
3400 East McDowell Road
Phoenix, AZ 85008
 
Dear Ms. Sullivan:
 
This is a correction to CBER’s February 29, 2012, approval letter for Thin Layer Rapid Use Epicutaneous Test (T.R.U.E. Test), regarding the pediatric study requirements.
 
Under the Pediatric Research Equity Act  (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in the pediatric age group unless this requirement is waived, deferred, or inapplicable.
 
We are waiving the pediatric study requirement for ages birth to < 6 years of age because the T.R.U.E. TEST does not represent a meaningful therapeutic benefit over diagnosis based on history and/or testing selectively with suspected allergens and is unlikely to be used in a substantial number of children younger than 6 years of age.
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
Sincerely yours,
 
 
 /s/
 
Wellington Sun, M.D.
Director
Division of Vaccines and
Related Product Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research