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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
State Compliance with Medicaid and CHIP Renewal Requirements by December 31, 2026  Centers for Medicare & Medicaid Services (CMS) Final
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Conducting Clinical Trials With Decentralized Elements  Food and Drug Administration (FDA) Final
CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies  Food and Drug Administration (FDA) Proposed
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry  Food and Drug Administration (FDA) Final
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)  Food and Drug Administration (FDA) Final
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3359 documents.

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