Draft Guidance for Industry: E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports-2024/3/13

Draft Guidance: Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products-2024/3/12

Draft Guidance: Early Alzheimer’s Disease: Developing Drugs for Treatment-2024/3/11

Final Guidance: Q14 Analytical Procedure Development-2024/3/6

Final Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry-2024/2/29

Final Guidance: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment-2024/2/21

Draft Guidance: Use of Data Monitoring Committees in Clinical Trials-2024/2/12

Draft Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products-2024/1/29

Final Guidance: Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry-2024/1/24

Draft Guidance: Quality Considerations for Topical Ophthalmic Drug Products-2023/12/27