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Vaccines, Blood & Biologics
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Resources for You
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Allergenics Guidances
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
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Allergenic Guidance Documents
- Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
11/20/2008 - Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
11/20/2000 - Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
4/23/1999
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Consumer Affairs Branch (CBER)
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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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