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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
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
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Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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