new drug application meaning in English
新药上市申请,注册新药
Examples
- Investigational new drug application
即新药临床试验申请 - New drug application
及新药上市许可申请 - Clinical trials conducted between regulatory submission of an nda ( new drug application ) and approval of a regulatory dossier for marketing authorization
旨在向药审机构递交了新药注册申请之后到申请药物被批准上市之前的一段时间内进行的相关药物临床试验 - 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。 - Fda is working with the manufacturers of pergolide to determine if it might be possible , once the drug is withdrawn from the market , to make the drug aailable under an inestigational new drug application ( ind ) for those few patients who are currently receiing pergolide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。