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Zdrowie i gospodarka · 25.08.1997

Draft Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts (July 1997).'' This draft guidance document is intended to provide information to manufacturers regarding the development of stability studies to determine the shelf life of standardized grass pollen extracts to help ensure the safety, purity, and potency of these products.

Source: Federal Register — Food and Drug AdministrationOpen original release →