Final Guidance: Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products-2023/12/21

Final Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations-2023/12/21

Draft Guidance for Industry: Master Protocols for Drug and Biological Product Development-2023/12/21

Final Guidance: Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization-2023/12/20

Draft Guidance: Advanced Manufacturing Technologies Designation Program FDA Creates New Advisory Committee for Evaluation of Genetic Metabolic Disease Treatments-2023/12/12

Draft Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act-2023/12/6

Draft Guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act - Revision 2-2023/12/6

Final Guidance: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Final Guidance: Submitting Patient-Reported Outcome Data in Cancer Clinical Trials-2023/11/3

Final Guidance: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory-2023/11/3