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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children  Food and Drug Administration (FDA) Final
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of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods  Food and Drug Administration (FDA) Proposed
Considerations for Complying with 21 CFR 211.110  Food and Drug Administration (FDA) Proposed
Advanced Manufacturing Technologies Designation Program  Food and Drug Administration (FDA) Final
M15 General Principles for Model-Informed Drug Development  Food and Drug Administration (FDA) Proposed
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
E11A Pediatric Extrapolation  Food and Drug Administration (FDA) Final
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3312 documents.

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