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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products  Food and Drug Administration (FDA) Proposed
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry   Food and Drug Administration (FDA) Proposed
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
How to Comply with the Pediatric Research Equity Act  Food and Drug Administration (FDA) Proposed
Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
In Vitro Diagnostic Multivariate Index Assays - Draft Guidance for Industry, Clinical Laboratories, and FDA Staff  Food and Drug Administration (FDA) Proposed
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 50115 documents.

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