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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
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry  Food and Drug Administration (FDA) Final
Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements : Guidance for Industry  Food and Drug Administration (FDA) Final
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry  Food and Drug Administration (FDA) Final
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires: Guidance for Industry  Food and Drug Administration (FDA) Final
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial: Guidance for Industry  Food and Drug Administration (FDA) Final
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes: Guidance for Industry  Food and Drug Administration (FDA) Final
Submission of Warning Plans for Cigars: Guidance for Industry  Food and Drug Administration (FDA) Final
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4041 documents.