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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Accelerated Approval – Expedited Program for Serious Conditions  Food and Drug Administration (FDA) Proposed
CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula  Food and Drug Administration (FDA) Proposed
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document  Food and Drug Administration (FDA) Proposed
E6(R3) Good Clinical Practice: Annex 2  Food and Drug Administration (FDA) Proposed
M15 General Principles for Model-Informed Drug Development  Food and Drug Administration (FDA) Proposed
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices  Food and Drug Administration (FDA) Proposed
Considerations for Complying with 21 CFR 211.110  Food and Drug Administration (FDA) Proposed
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway  Food and Drug Administration (FDA) Proposed
Considerations for Including Tissue Biopsies in Clinical Trials  Food and Drug Administration (FDA) Proposed
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