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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies: Considerations for Study Design   Food and Drug Administration (FDA) Proposed
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports  Food and Drug Administration (FDA) Proposed
Community-Acquired Bacterial Pneumonia — Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry  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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry  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
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