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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
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
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex  Food and Drug Administration (FDA) Proposed
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submitting Debarment Certification Statements  Food and Drug Administration (FDA) Proposed
Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Modified Risk Tobacco Product Applications: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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