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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
Best Practices for Communication Between IND Sponsors and FDA During Drug Development  Food and Drug Administration (FDA) Final
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets  Food and Drug Administration (FDA) Final
Bioanalytical Method Validation Guidance for Industry  Food and Drug Administration (FDA) Final
Bioavailability Studies Submitted in NDAs or INDs – General Considerations  Food and Drug Administration (FDA) Final
Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components  Food and Drug Administration (FDA) Final
Bioresearch Monitoring Technical Conformance Guide  Food and Drug Administration (FDA) Final
Bispecific Antibody Development Programs Guidance for Industry  Food and Drug Administration (FDA) Final
Blood Lancet Labeling - Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Botanical Drug Development: Guidance for Industry  Food and Drug Administration (FDA) Final
Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.