| 查看: 792 | 回复: 0 | |||
ienjoysun银虫 (著名写手)
|
[交流]
FDA Releases Draft Guidance on Using the Inactive Ingredient Database
|
|
FDA Releases Draft Guidance on Using the Inactive Ingredient Database The draft guidance provides industry with a guide for using the database to assist in the development of drug products. Jul 10, 2019 By Pharmaceutical Technology Editors On July 10, 2019, FDA published draft guidance for public comment on the use of the Inactive Ingredient Database (IID). The guidance document provides information on how to use the IID when choosing inactive ingredients in the development of new drug products. The guidance also supports the agency’s efforts in the promotion of generic drugs as part of its Drug Competition Action Plan. The guidance also describes how the agency uses the IID to support the safety of inactive ingredients. It describes the structure of the IID, the process for adding ingredients to the IID, and how information is presented in the database, which gives users a better understanding of how to use the information. The IDD lists information on inactive ingredients used in FDA-approved drug products. Once an inactive ingredient is used in an approved drug for a specific route of administration it is not considered novel; therefore, the ingredient may not require extensive review by the agency the next time it is used in a new product. Source: FDA |
回复此楼» 猜你喜欢
2026年申博药学专业
已经有1人回复
-
药学专硕申博
已经有18人回复
-
药物学论文润色/翻译怎么收费?
已经有207人回复
-
可能上不了岸？有条件的可以考虑其他出路
已经有0人回复
-
分子对接相关经验分享
已经有0人回复
-
分子对接相关经验分享
已经有0人回复
-
这个自发加氧反应的机理是什么？
已经有7人回复
-
2026生物医药产业发展大会
已经有0人回复
-
国青中了
已经有23人回复
-
:D多个国家或地区的农药法规&登记情况查询网站
已经有0人回复
