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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
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor…  Food and Drug Administration (FDA) Proposed
Mandatory Medicaid Coverage of Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials  Centers for Medicare & Medicaid Services (CMS) Final
Tobacco Product User Fees: Responses to Frequently Asked Questions  Food and Drug Administration (FDA) Final
IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports  Food and Drug Administration (FDA) Final
Development of Anti-Infective Drug Products for the Pediatric Population : 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
Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.