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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Questions and Answers on Current Good Manufacturing Practices for Drugs  Food and Drug Administration (FDA) Final
Real World Data / Real World Evidence RWD/RWE  Food and Drug Administration (FDA) Final
Redbook 2000: I Introduction  Food and Drug Administration (FDA) Final
Redbook 2000: III Recommended Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV. A. Introduction to Guidelines for Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV.B.1. General Guidelines for Designing and Conducting Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV.B.2 Guidelines for Reporting the Results of Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV.B.3. Pathology Considerations in Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV.B.4. Statistical Considerations in Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV.C.1. Short-Term Tests for Genetic Toxicity  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.