Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
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
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Independent Consultants for Biotechnology Clinical Trial Protocols: Guidance for Industry  Food and Drug Administration (FDA) Final
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Industry Supported Scientific and Educational Activities: Guidance for Industry  Food and Drug Administration (FDA) Final
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.