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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.
premarketing-risk-assessment Drug Test
  • January 31, 2025

Premarketing Risk Assessment

Guidance for Industry – Premarketing Risk Assessment, Clinical/Medical
best-practices-for-conducting-and-reporting-pharmacoepidemiologic-safety-studies-using-electronic-healthcare-data-sets Drug Test
  • January 31, 2025

Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets

Drug Safety
optimizing-postapproval-safety-studies-to-expand-data-generation-on-medication-use-in-pregnancy Drug Test
  • January 31, 2025

Optimizing Postapproval Safety Studies to Expand Data Generation on Medication Use in Pregnancy

Postapproval pregnancy safety studies (or studies that focus on medication use after approval) can help guide clinical practice and provide…
m4s:-the-ctd-—-safety Drug Test
  • January 31, 2025

M4S: The CTD — Safety

International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary)