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FDA Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry
Content:
Standardized grass pollen extracts must demonstrate their potency in accordance with 21 CFR 680.3(e), 610.10, and 600.3(s). Accordingly, manufacturers must demonstrate that their grass pollen extracts maintain potency and are stable until the product's expiration date. The Center for Biologics Evaluation and Research (CBER) is setting forth this document to provide guidance on developing stability protocols for standardized grass pollen extracts.

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