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GUIDANCE DOCUMENT

Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol Guidance for Reviewers November 2000

Final
Docket Number:
00D-0218
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The release limits for standardized dust mite and grass allergen vaccines are based on the performance characteristics of the competition Enzyme-Linked Immunosorbent Assay (ELISA) for the determination of the relative potency (RP) of these products. Using this assay, Center for Biologics Evaluation and Research (CBER) has required (21 CFR 680.3(e)) that all lots of these products be shown to be equivalent to the reference standard, with 95% confidence. Thus, the limits have been set at 0.70-1.43 for three determinations; when six determinations are made, the limits are 0.78-1.29.

 


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 00D-0218.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010