2020 年：药物批准创纪录的一年。

2020: A Record Year for Drug Approvals.

机构信息

Senior Director of Quality, Omnicare.

出版信息

Sr Care Pharm. 2021 Apr 1;36(4):174-175. doi: 10.4140/TCP.n.2021.174.

DOI:10.4140/TCP.n.2021.174

Abstract

In 2020 The United States Food and Drug Administration?s (FDA) Center for Drug Evaluation and Research (CDER) approved 53 novel drugs, five more than in 2019, but still an aggressive number when compared with 2015 when only 45 new drugs were released to the market. CDER, the largest department within the FDA, has robustly approved a rising number of generic drugs in the last several years, increasing their accessibility and reducing patient and payor costs.

摘要

2020 年，美国食品和药物管理局（FDA）的药品评估和研究中心（CDER）批准了 53 种新的药物，比 2019 年多了 5 种，但与 2015 年相比，当年只有 45 种新药投放市场，这仍然是一个很高的数字。CDER 是 FDA 内最大的部门，在过去几年中，该部门大力批准了越来越多的仿制药，增加了这些药品的可及性，降低了患者和支付方的成本。