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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
Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry  Food and Drug Administration (FDA) Final
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance: Guidance for Industry  Food and Drug Administration (FDA) Final
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry  Food and Drug Administration (FDA) Final
Pharmaceutical Components at Risk for Melamine Contamination: Guidance for Industry  Food and Drug Administration (FDA) Final
Pharmacogenomic Data Submissions: Guidance for Industry  Food and Drug Administration (FDA) Final
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer: Guidance for Industry  Food and Drug Administration (FDA) Final
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol: Guidance for Industry  Food and Drug Administration (FDA) Final
Population Pharmacokinetics: Guidance for Industry  Food and Drug Administration (FDA) Final
Pre-Launch Activities Importation Requests (PLAIR): Guidance for Industry  Food and Drug Administration (FDA) Final
Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.