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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
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Labeling for Combined Hormonal Contraceptives Guidance for Industry  Food and Drug Administration (FDA) Proposed
Labeling for Biosimilar and Interchangeable Biosimilar Products  Food and Drug Administration (FDA) Proposed
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
M10 BIOANALYTICAL METHOD VALIDATION  Food and Drug Administration (FDA) Proposed
Innovative Approaches for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.