Zdrowie i gospodarka · 15/02/2000
Draft “Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol" dated January, 2000. The draft guidance document provides information on the revised release limits to be used by the Center for Biologics Evaluation and Research (CBER) for its evaluation of standardized dust mite and grass allergen vaccines submitted to CBER for lot release. The establishment of suitable potency limits for standardized allergen vaccines submitted to CBER for lot release helps to ensure the safety, purity, and potency of these products.