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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06  Food and Drug Administration (FDA) Proposed
Current Good Manufacturing Practice for Medical Gases: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Male Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Product Labeling for Laparoscopic Power Morcellators: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
NEPQR-Veterans Bachelor of Science Nursing (VBSN) Annual Performance Report  Health Resources and Services Administration (HRSA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part IX FDA References  Food and Drug Administration (FDA) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
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