FDA：2018年度新药评审报告(英文版)(36页).pdf

1、www.fda.gov January 2019 www.fda.gov January 2019 ADVANCING HEALTH THROUGH INNOVATION 2018 NEW DRUG THERAPY APPROVALS Impact | Innovation | Predictability | Access CENTER FOR DRUG EVALUATION AND RESEARCH 2 Advancing Health Through Innovation Table of Contents Introduction .3 2018: Another Strong Yea

2、r for Innovation and Advances .4 Novel Drugs .7 Impact of Novel Drug Approvals .9 Innovation: Frequent Use of Expedited Development and Review Pathways . 18 Predictability: Meeting PDUFA Goals .20 Access: First Cycle Approval and Approvals Compared to Other Countries . 21 New and Expanded Uses of Al

3、ready FDA-Approved Drugs .22 New Uses .22 New Populations .25 Additional Approvals .26 Biosimilars .26 New Formulations and Other Notable Approvals .28 New Dosage Forms .30 Conclusion .31 Appendix A: Drug Designation Summary .32 Appendix B: Novel Drug Designation Summary.34 2018 New Drug Therapy App

4、rovals 3 Introduction Welcome to the FDAs Center for Drug Evaluation and Researchs (CDER) annual report, Advancing Health Through Innovation: New Drug Therapy Approvals. This report helps illustrate CDERs role in bringing innovative new drug therapies that are safe and effective to patients in need.

5、 Many of this years new drug therapies are novel drugs - those never before approved or marketed in the United States. Novel drugs often represent important new therapies for advancing patient care. Our report also highlights medically significant approvals for existing drugs. As in past years, many

6、 important advances in 2018 use an already FDA-approved drug to treat a new disease or a new population of patients, such as children. Our report emphasizes some of the many innovative ways we were able to evaluate safety and efficacy for these new therapies, as well as key regulatory tools we used