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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions  Food and Drug Administration (FDA) Final
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
ANDAs: Stability Testing of Drug Substances and Products  Food and Drug Administration (FDA) Final
ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers  Food and Drug Administration (FDA) Final
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule - Concept Paper  Food and Drug Administration (FDA) Final
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09  Food and Drug Administration (FDA) Final
Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Annex 13 Bulk Density and Tapped Density of Powders General Chapter  Food and Drug Administration (FDA) Final
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3315 documents.

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