作者: EthanLin
FDA: Cellular & Gene Therapy Products
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.
CAR T-Cell Therapy: Engineering Patients’ Immune Cells to Treat Their Cancers
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.
FDA letter: Lymphocyte Immune Therapy (LIT) Letter
Department of Health and Human Services
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
药物与生物制剂有何不同(英文)?
How do Drugs and Biologics Differ?
https://www.bio.org/articles/how-do-drugs-and-biologics-differ
How to Eat Sushi Without Embarrassing Yourself
转Tyler Moss 2016年10月8日的文章:怎样吃寿司才不会尴尬自己?