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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)  Food and Drug Administration (FDA) Final
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry  Food and Drug Administration (FDA) Final
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development  Food and Drug Administration (FDA) Final
S10 Photosafety Evaluation of Pharmaceuticals  Food and Drug Administration (FDA) Final
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Final
S1B Testing for Carcinogenicity of Pharmaceuticals  Food and Drug Administration (FDA) Final
S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Final
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use  Food and Drug Administration (FDA) Final
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals  Food and Drug Administration (FDA) Final
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3359 documents.

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