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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)  Food and Drug Administration (FDA) Final
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event  Food and Drug Administration (FDA) Proposed
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers  Food and Drug Administration (FDA) Final
Advanced Manufacturing Technologies Designation Program  Food and Drug Administration (FDA) Final
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices  Food and Drug Administration (FDA) Proposed
E6(R3) Good Clinical Practice: Annex 2  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3298 documents.

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