Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Submissions

Search HHS Guidance Documents

 

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending 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Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Material Threat Medical Countermeasure Priority Review Vouchers - Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Modified Risk Tobacco Product Applications: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 28730 documents.

Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

CDC

CMS

* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.