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Standardized grass pollen extract transition period is possible, FDA indicates.

Executive Summary

STANDARDIZED GRASS POLLEN EXTRACT TRANSITION PERIOD COULD BE ALLOWED by FDA, the agency has indicated. In April 1994, FDA informed allergenic product manufacturers that eight varieties of grass pollen extracts must be standardized to bioequivalent allergy units. The deadline for changeover was initially April 1996; it was subsequently extended to July 1997, but to date only two manufacturers have received approvals.
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PS030343

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