NDA FIELD ALERTS

meiwenguigui

有哪位前辈可以帮忙介绍一下NDA FIELD ALERTS 是什么意思吗？是有关新药申请领域的吗，多谢！

beiwei5du

B. NDA Field Alert Reports (FARs) The NDA/ANDA Field Alert reporting requirements, 21 CFR 314.81(b)(1)(i) and (ii), becameeffective on May 23, 1985. The regulation requires holders of NDAs and ANDAs “to submitcertain information about distributed drug products” to the jurisdictional FDA district officeswithin three working days. The 3 working days begins when the applicant becomes aware of areported problem through either a complaint or internal testing. It does not begin the day theapplicant confirms or invalidates a problem. FARs may be reported via telephone or other meansof rapid communication with prompt written follow-up. The FAR and its mailing cover shouldbe plainly marked: “NDA-Field Alert Report”. Form FDA 3331 (References Part VI A)provides a standardized form for applicants to report.

这个是NDA持有者在意识到自己的产品有某些问题的时候，及时通知FDA的一种方式。

beiwei5du

我在想这个到底有什么用处呢？？？？