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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #239 Human Food By-Products For Use As Animal Food  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling  Food and Drug Administration (FDA) Proposed
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation  Food and Drug Administration (FDA) Proposed
Good ANDA Submission Practices Guidance for Industry  Food and Drug Administration (FDA) Proposed
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Mouse Embryo Assay for Assisted Reproduction Technology Devices  Food and Drug Administration (FDA) Proposed
Pharmacogenomic Data Submissions — Companion Guidance  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 49441 documents.

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