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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
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees: Guidance for Industry  Food and Drug Administration (FDA) Final
M4: The CTD -- General Questions and Answers  Food and Drug Administration (FDA) Final
Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
M4: The CTD -- Efficacy Questions and Answers  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for Industry  Food and Drug Administration (FDA) Final
CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores  Food and Drug Administration (FDA) Final
CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention  Food and Drug Administration (FDA) Final
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Proposed
Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4132 documents.