Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage: Guidance for Industry  Food and Drug Administration (FDA) Final
Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry  Food and Drug Administration (FDA) Final
Process Validation: General Principles and Practices: Guidance for Industry  Food and Drug Administration (FDA) Final
Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Product Recalls, Including Removals and Corrections: Guidance for Industry  Food and Drug Administration (FDA) Final
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
Prohibition of Distributing Free Samples of Tobacco Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.