新药申请 meaning in Chinese
new drug a lication， nda
new drug application nda
new drug application, nda
Examples
- In addition , pending new drug applications ( nda ) , abbreviated new drug applications ( anda ) , or export approval requests may not be approved until the aforementioned deviations are corrected
此外，还未决定的新药申请（ nda ） 、简略新药申请（ anda ）以及出口批准申请可能不会被批准，直到上述偏差已得到整改。 - Abstract : starting with the examinational procedure and technique specification of new drug license application in china andusa , the differences between two countries in definition of new drug and its classification , clinical study and the new drug license application are compared . development trend of international examinational system and some relevant countermeasures of china are introduced . also , scientific progress of china ' s regulations of application in new drug license to approach the international standard are analyzed
文摘:从中美两国新药审批程序和技术要求入手，对新药的定义、分类、审批程序、新药临床研究申请和新药申请等方面的异同进行了比较和客观评析，介绍了国际新药审评制度发展新动向和我国新药审批办法的若干改革举措，分析了我国新药审批办法与国际接轨的科学化进程 - Fda is working with the manufacturers of pergolide to determine if it might be possible , once the drug is withdrawn from the market , to make the drug aailable under an inestigational new drug application ( ind ) for those few patients who are currently receiing pergolide and who cannot be successfully conerted to other aailable treatments
Fda正在与培高利特生产厂商进行协商，一旦该药撤市后，对于那些少数目前正在使用该药而不能成功改换其他药物治疗的患者，是否可在“试验新药申请”许可下进行使用该药的可能性。