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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Osteoarthritis: Structural Endpoints for the Development of Drugs  Food and Drug Administration (FDA) Proposed
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Proposed
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans  Food and Drug Administration (FDA) Proposed
Pharmacogenomic Data Submissions — Companion Guidance  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Proposed
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