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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Exculpatory Language in Informed Consent  Food and Drug Administration (FDA) Proposed
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers  Food and Drug Administration (FDA) Proposed
Fabry Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief  Food and Drug Administration (FDA) Proposed
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry  Food and Drug Administration (FDA) Final
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs  Food and Drug Administration (FDA) Proposed
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.