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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products   Food and Drug Administration (FDA) Proposed
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Providing Submissions in Electronic Format — Postmarketing Safety Reports  Food and Drug Administration (FDA) Proposed
Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act  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Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999  Food and Drug Administration (FDA) Proposed
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
Office Based Opioid Use Disorder Treatment Billing  Centers for Medicare & Medicaid Services (CMS) Proposed
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommended Methods for Blood Grouping Reagents Evaluation: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 47362 documents.

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