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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
Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Material Threat Medical Countermeasure Priority Review Vouchers - Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Modified Risk Tobacco Product Applications: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.