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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
Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers  Food and Drug Administration (FDA) Final
Providing Submissions in Electronic Format — Postmarketing Safety Reports  Food and Drug Administration (FDA) Final
Prussian Blue Drug Products — Submitting a New Drug Application  Food and Drug Administration (FDA) Final
Psychoactive Drugs in Infants and Children--Clinical Evaluation  Food and Drug Administration (FDA) Final
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Pyrogen and Endotoxins Testing: Questions and Answers  Food and Drug Administration (FDA) Final
Q10 Pharmaceutical Quality System  Food and Drug Administration (FDA) Final
Q11 Development and Manufacture of Drug Substances  Food and Drug Administration (FDA) Final
Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)  Food and Drug Administration (FDA) Final
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.