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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
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)  Food and Drug Administration (FDA) Final
Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory  Food and Drug Administration (FDA) Final
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products  Food and Drug Administration (FDA) Final
Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document  Food and Drug Administration (FDA) Final
Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Final
Submitting Patient-Reported Outcome Data in Cancer Clinical Trials  Food and Drug Administration (FDA) Final
Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications  Food and Drug Administration (FDA) Final
Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process  Food and Drug Administration (FDA) Final
Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry  Food and Drug Administration (FDA) Final
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.