Allergenics Publications
Inspections and Compliance
Guidances and Rules
- Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol - 11/20/2000
- Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts - 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
- Federal Register: Food and Drug Administration Modernization Act of 1997; Allergenic Patch Test Kits; Request for Comments or Data - 10/1/1998