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patient-engagement-collaborative Drug Test
  • January 31, 2025

Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and…
s7a-safety-pharmacology-studies-for-human-pharmaceuticals Drug Test
  • January 31, 2025

S7A Safety Pharmacology Studies for Human Pharmaceuticals

International Council on Harmonisation – Safety
pharmacokinetics-in-patients-with-impaired-hepatic-function:-study-design,-data-analysis,-and-impact-on-dosing-and-labeling Drug Test
  • January 31, 2025

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

Clinical Pharmacology
patient-focused-drug-development:-methods-to-identify-what-is-important-to-patients Drug Test
  • January 31, 2025

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

Procedural Guidance
clinical-studies-section-of-labeling-for-human-prescription-drug-and-biological-products-—-content-and-format Drug Test
  • January 31, 2025

Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

Guidance for Industry – Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format,…
hospital-acquired-bacterial-pneumonia-and-ventilator-associated-bacterial-pneumonia:-developing-drugs-for-treatment Drug Test
  • January 31, 2025

Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment

Clinical / Antimicrobial
clinical-development-programs-for-drugs,-devices,-and-biological-products-for-the-treatment-of-rheumatoid-arthritis-(ra) Drug Test
  • January 31, 2025

Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)

Clinical/Medical
clinical-pharmacogenomics:-premarket-evaluation-in-early-phase-clinical-studies-and-recommendations-for-labeling Drug Test
  • January 31, 2025

Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling

Clinical Pharmacology
chronic-rhinosinusitis-with-nasal-polyps:-developing-drugs-for-treatment Drug Test
  • January 31, 2025

Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment

Clinical / Medical
recently-issued-guidance-documents Drug Test
  • January 31, 2025

Recently Issued Guidance Documents

This page lists Recently Issued CBER and Cross-Center Guidance Documents.