Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
Clinical/Medical
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment
Clinical / Medical
Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
Premarketing Risk Assessment
Guidance for Industry – Premarketing Risk Assessment, Clinical/Medical
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
International Council on Harmonisation – Joint Safety/Efficacy (Multidisciplinary)
Research in Progress | Office of Prescription Drug Promotion (OPDP) Research
Research in Progress | Office of Prescription Drug Promotion Research
Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research
Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research