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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
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption  Food and Drug Administration (FDA) Proposed
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently…  Food and Drug Administration (FDA) Proposed
Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions  Food and Drug Administration (FDA) Proposed
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry  Food and Drug Administration (FDA) Proposed
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Proposed
Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act  Food and Drug Administration (FDA) Proposed
REMS Logic Model: A Framework to Link Program Design With Assessment  Food and Drug Administration (FDA) Proposed
REMS Assessment: Planning and Reporting  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4742 documents.