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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 for Nasal Aerosols and Nasal Sprays for Local Action  Food and Drug Administration (FDA) Proposed
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)  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 Rescinding Breakthrough Therapy Designation  Food and Drug Administration (FDA) Proposed
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications  Food and Drug Administration (FDA) Proposed
CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines  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
Clinical Pharmacology Considerations for Peptide Drug Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3214 documents.

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