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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
Formatting, Assembling and Submitting New Drug and Antibiotic Applications*  Food and Drug Administration (FDA) Final
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry  Food and Drug Administration (FDA) Final
General Considerations for the Clinical Evaluation of Drugs  Food and Drug Administration (FDA) Final
General Guidelines for OTC Combination Products  Food and Drug Administration (FDA) Final
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry  Food and Drug Administration (FDA) Final
General/Specific Intended Use - Guidance for Industry  Food and Drug Administration (FDA) Final
Good ANDA Submission Practices Guidance for Industry  Food and Drug Administration (FDA) Final
Good Laboratory Practice Regulations Questions and Answers  Food and Drug Administration (FDA) Final
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier  Food and Drug Administration (FDA) Final
Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.