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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
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry  Food and Drug Administration (FDA) Final
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for Industry  Food and Drug Administration (FDA) Final
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry  Food and Drug Administration (FDA) Final
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry  Food and Drug Administration (FDA) Final
FDA Export Certification: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.