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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration  Food and Drug Administration (FDA) Proposed
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Proposed
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers  Food and Drug Administration (FDA) Proposed
Early Alzheimer’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
E6(R3) GOOD CLINICAL PRACTICE (GCP)  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Menu Labeling Supplemental Guidance (Edition 2)  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
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