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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Field Alert Report Submission: Questions and Answers Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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