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Zdrowie i gospodarka · 20.11.2000

"Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts"; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts" dated November 2000. The guidance document provides information on developing stability protocols for standardized grass pollen extracts. The development of suitable stability studies is necessary to determine the shelf life of standardized grass pollen extracts to help ensure the safety, purity, and potency of these products. The guidance document announced in this notice finalizes the draft guidance entitled "Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts" that was announced in the Federal Register of August 25, 1997.

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