美国FDA药物评价和研究中心（CDER）：2022年度新药获批报告（英文版）（34页）.pdf

1、CENTER FOR DRUG EVALUATION AND RESEARCHINNOVATION PREDICTABILITY ACCESSJanuary 2023Advancing Health Through Innovation:New Drug Therapy Approvals 2022 iiAdvancing Health Through Innovation:New Drug Therapy Approvals 2022Table of ContentsDirectors Message.1Executive Summary.3CDERs Novel Drug Approval

2、s of 2022.5First-in-Class Drugs.6Drugs for Rare Diseases.7Other Novel Drug Approvals.9Innovation:Expedited Development and Review Pathways.10Fast Track.10Breakthrough Therapy.11Priority Review.11Accelerated Approval.12Overall Use of Expedited Development and Review Methods.12Predictability:Meeting P

3、DUFA Goals.13Access:First Cycle Approvals and First in U.S.Approvals.14New Uses of Approved Drugs.16Approved Drugs Expanded for New Pediatric Populations.20Biosimilar and Interchangeable Biosimilar Approvals.22Other CDER Actions.25Conclusion.26Appendix A:CDERs Novel Approvals of 2022.27Appendix B:No

4、vel Drug Designations.30 1Advancing Health Through Innovation:New Drug Therapy Approvals 2022Directors MessageWelcome to FDAs Center for Drug Evaluation and Researchs(CDER)12th itera-tion of the annual report,Advancing Health Through Innovation:New Drug Therapy Approvals.This report showcases our ro

5、le in bringing drug therapies to patients that are safe and effective.2022 marked the third consecutive year that COVID-19 has taken its toll on the global community.Mpox also emerged as a public health concern.Despite these hardships,we approved many therapies to prevent,diagnose,and treat a wide r

6、ange of diseases and conditions.Our report highlights CDERs novel approvals of 2022 that will make a difference in peoples lives.The report also illustrates the ways we evaluated drug safety and efficacy,as well as the regulatory tools we used to review and approve drug applications.We approved almo