| 查看: 1110 | 回复: 4 | |||||||
1949stone荣誉版主 (知名作家)
海纳百川
|
[交流]
New Drugs at FDA 已有4人参与
|
 http://www.fda.gov/Drugs/Develop ... ovation/default.htm New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products 2014 Novel New Drugs Summary 2014 Novel New Drugs Summary (PDF - 13MB) Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, FDA provides scientific and regulatory advice needed to bring new therapies to market. The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development. Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. Graph symbol View animated charts from the 2014 Novel New Drugs Summary publication on the right. (Not viewable in Internet Explorer version 7 and below.)  |
回复此楼» 本帖附件资源列表
-
欢迎监督和反馈：小木虫仅提供交流平台，不对该内容负责。
本内容由用户自主发布，如果其内容涉及到知识产权问题，其责任在于用户本人，如对版权有异议，请联系邮箱：xiaomuchong@tal.com - 附件 1 : Novel_New_Drugs_2014_Summary.pdf
2015-01-16 10:27:25, 8.55 M
» 收录本帖的淘帖专辑推荐
 颛顼药学 | 药物研发知识 | 搜藏-精-实 | 研发专用 |
» 猜你喜欢
2026申博
已经有0人回复
-
合成
已经有0人回复
-
药物学论文润色/翻译怎么收费?
已经有270人回复
-
氨基酸的酰化反应，求大佬解答
已经有0人回复
-
26年申博——已发SCI6篇
已经有13人回复
-
碱缸的配制
已经有5人回复
-
新！澳门科技大学诚招2026年秋季药剂学/生物材料方向博士研究生（申请-考核制）
已经有18人回复
-
澳科大药学院诚招2026年秋季纳米医学/生物材料博士研究生
已经有16人回复
-
医药口服制剂辅料应用
已经有0人回复
-
全新推出Tguide®靶向递送方案，突破99% T细胞转染效率
已经有1人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- 大家对诺华诺德的 Semaglutide 前景怎么看？
已经有11人回复
- FDA中提到的NMEs（New Molecular Entity 新分子实体）包括生物制品吗？
已经有4人回复
- 求助布地奈德的用途的文献，妹子不胜感激
已经有4人回复
- FDA批准新药Hemangeol上市
已经有7人回复
- 怎样能查到FDA刚批准上市新药的信息？
已经有7人回复
- FDA延迟批准葛兰素史克GLP-1药物阿必鲁肽
已经有7人回复
- 正大天晴3000万美元买入一个临床前抗HCV药物在中国地区的许可，天价?
已经有15人回复
- Purdue Pharma：如何让一个药独占市场30年？
已经有9人回复
- FDA批准强生Canagliflozin用于2型糖尿病
已经有8人回复
- 关于New dosage form 和New formulation or new manufacturer 的翻译问题
已经有5人回复
- 如何查上市药物的药理毒理资料？
已经有8人回复
- 2011 FDA drug approvals
已经有57人回复
- 阿尼芬净的专利求助
已经有12人回复
- 3类化药药效学试验剂量组的设置
已经有22人回复
- 转：具有全新降低血糖机制的新药被fda专家小组否定
已经有3人回复
- 【转帖】药品查询网的数据库
已经有77人回复
- 【转帖】杜克之问：药物试验全球化，到底谁受益？
已经有16人回复
- 【转帖】国产PVP遭遇FDA发难，过氧化物超标
已经有7人回复
谢谢分享 |
2楼2015-01-16 10:37:55
|
谢谢分享 [ 发自小木虫客户端 ] |
3楼2015-01-17 06:56:20
臭笨笨
木虫 (正式写手)
- 应助: 82 (初中生)
- 金币: 1771.3
- 散金: 219
- 红花: 3
- 帖子: 834
- 在线: 205.2小时
- 虫号: 3064652
- 注册: 2014-03-17
- 性别: GG
- 专业: 药剂学
4楼2015-01-17 15:51:29
| 感谢分享 |
5楼2015-01-19 08:39:02