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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products  Food and Drug Administration (FDA) Proposed
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
CPG Sec 100.101 Crotalaria spp. Seeds in Grains  Food and Drug Administration (FDA) Proposed
CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines  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
Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3307 documents.

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