作者： EthanLin

The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight. 阅读更多 (Read More)

Abstract 阅读更多 (Read More)

For years, the cornerstones of cancer treatment have been surgery, chemotherapy, and radiation therapy. Over the last decade, targeted therapies like imatinib (Gleevec®) and trastuzumab (Herceptin®)—drugs that target cancer cells by homing in on specific molecular changes seen primarily in those cells—have also emerged as standard treatments for a number of cancers. 阅读更多 (Read More)

Department of Health and Human Services
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448 阅读更多 (Read More)

"生物治疗一种新兴的自身免疫的新型治疗方法，又称生物反应修饰剂，目前多应用于癌症，主要思想是运用生物技术和制剂对病人体内吸取的免疫细胞进行体外改造和扩增后回输到病人体内，极大化增强生物自愈能力来抗病。也是一种个人化医疗趋势产物。" 阅读更多 (Read More)

How do Drugs and Biologics Differ?

https://www.bio.org/articles/how-do-drugs-and-biologics-differ 阅读更多 (Read More)