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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort descending
MLN Product (Revised): MLN6805343 - Repetitive, Scheduled Non-Emergent Ambulance Transport Prior Authorization Model  Centers for Medicare & Medicaid Services (CMS) Final
MLN3754874 - Ordering External Breast Prostheses and Supplies  Centers for Medicare & Medicaid Services (CMS) Final
Considerations for Complying with 21 CFR 211.110  Food and Drug Administration (FDA) Proposed
Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children  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Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event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
Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods  Food and Drug Administration (FDA) Proposed
Study of Sex Differences in the Clinical Evaluation of Medical Products  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)  Food and Drug Administration (FDA) Final
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
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