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HHS Guidance Submissions

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Applications Covered by Section 505(b)(2)  Food and Drug Administration (FDA) Proposed
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs  Food and Drug Administration (FDA) Proposed
Community-Acquired Bacterial Pneumonia — Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods for Voluntary Sodium Reduction Goals  Food and Drug Administration (FDA) Proposed
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
Innovative Approaches for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
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