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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
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
Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)  Food and Drug Administration (FDA) Final
Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs  Food and Drug Administration (FDA) Final
Systemic Lupus Erythematosus --Developing Medical Products for Treatment  Food and Drug Administration (FDA) Final
Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation  Food and Drug Administration (FDA) Final
Testicular Toxicity: Evaluation During Drug Development  Food and Drug Administration (FDA) Final
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.