2021创新药年度报告Office Of New Drugs 2021 Annual Report Final（英）.pdf

OFFICE OF NEW DRUGS 2021 ANNUAL REPORT CENTER FOR DRUG EVALUATION AND RESEARCH June 2022 iii Table of Contents Director’s Message v OND Exemplifies Scientific Leadership 1 OND by the Numbers in Calendar Year 2021 3 Scientific Leadership in Response to COVID-19 4 Innovative Trial Design for COVID-19 Therapies 4 Progression in Product Development 4 Innovations in Drug Trial Design 7 New Drug Development Programs for Innovative Trial Design 7 Innovative Trial Designs for New Patient Populations 8 Innovations in Using Data to Develop New Trial Designs and Treatments 9 Clinical Trial Advancements for Transdermal Drug Delivery 10 Innovative Consumer Behavior Studies for the Nonprescription Drug Market 10 Progression in Product Development 11 Drug and Therapy Approvals 11 Drug Development Tools and Programs 14 Initiative Highlight: OND Science Strategies 15 Guidance Supporting Product Development 16 Regulatory Advancements18 Collaboration and Information Sharing 22 OND Future Outlook 25 Appendix: Acronyms 27 2021 Annual Report iv OFFICE OF NEW DRUGS v Director’s Message In this Annual Report, we have focused on the importance of scientific leadership — in the era of COVID-19, that seems timely. Over the past two decades, the types