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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
Product Development Under the Animal Rule  Food and Drug Administration (FDA) Final
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry  Food and Drug Administration (FDA) Final
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final  Food and Drug Administration (FDA) Final
Proposed Approach to Regulation of Cellular and Tissue-Based Products  Food and Drug Administration (FDA) Final
Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection  Food and Drug Administration (FDA) Final
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.  Food and Drug Administration (FDA) Final
Providing Over-the-Counter Monograph Submissions in Electronic Format  Food and Drug Administration (FDA) Final
Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format -- Standardized Study Data  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.