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 ...

Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
S5(R3) Detection of Toxicity to Reproduction  Food and Drug Administration (FDA) Proposed
Safety Assessment for IND Safety Reporting Guidance for Industry  Food and Drug Administration (FDA) Proposed
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors  Food and Drug Administration (FDA) Proposed
Sample formats for Form FDA 356h_2011  Food and Drug Administration (FDA) Proposed
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products  Food and Drug Administration (FDA) Proposed
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry  Food and Drug Administration (FDA) Proposed
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Proposed
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 49907 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.