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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products  Food and Drug Administration (FDA) Proposed
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs  Food and Drug Administration (FDA) Proposed
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chinese Translation of Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 2010年5月)  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
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