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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Validation and Verification of Analytical Testing Methods Used for Tobacco Products  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
Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods  Food and Drug Administration (FDA) Proposed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
MM13918: Billing Instructions: Expedited Determinations Based on Medicare Change of Status Notifications  Centers for Medicare & Medicaid Services (CMS) Final
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
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
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
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)  Food and Drug Administration (FDA) Final
MLN3754874 - Ordering External Breast Prostheses and Supplies  Centers for Medicare & Medicaid Services (CMS) Final
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