FDA原辅包登记*DMF
Site information
药物主文件,即Drug Master File (DMF),是呈交FDA的存档待审资料,资料内容包括有关在制造、加工、包装、储存、批发人用药品活动中所使用的生产设施、工艺流程、质量控制及其所用原料、包装材料等详细信息。
Highlights
The FDA website provides a list of Drug Master Files (DMFs) that have been submitted to the FDA. DMFs are used to provide information about the safety and effectiveness of drug products. The list includes the name of the drug product, the name of the manufacturer, and the date the DMF was submitted. This information can be useful for researchers, manufacturers, and consumers who want to learn more about the safety and effectiveness of drug products.