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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
Human Gene Therapy for Rare Diseases: Guidance for Industry  Food and Drug Administration (FDA) Final
Human Gene Therapy for Retinal Disorders: Guidance for Industry  Food and Drug Administration (FDA) Final
Human Gene Therapy Products Incorporating Human Genome Editing: Guidance for Industry  Food and Drug Administration (FDA) Final
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components: Guidance for Industry  Food and Drug Administration (FDA) Final
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for Industry  Food and Drug Administration (FDA) Final
Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies: Guidance for Industry  Food and Drug Administration (FDA) Final
Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Inclusion of Older Adults in Cancer Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting: Guidance for Industry  Food and Drug Administration (FDA) Final
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.