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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 Regulatory Submissions in Electronic Format--Receipt Date: Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications: Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines: Guidance for Industry  Food and Drug Administration (FDA) Final
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Q13 Continuous Manufacturing of Drug Substances and Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Questions and Answers | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.