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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
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 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
Real-Time Oncology Review (RTOR) : Guidance for Industry  Food and Drug Administration (FDA) Final
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4041 documents.