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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
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry  Food and Drug Administration (FDA) Final
Premarketing Risk Assessment: Guidance for Industry  Food and Drug Administration (FDA) Final
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment: Guidance for Industry  Food and Drug Administration (FDA) Final
Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4735 documents.