4、FDA Debarment List 在NDA或ANDA的药物开发、批准过程中,触犯联邦法规而犯下重罪的公司或者人员名单。即黑名单。从本list中,可查询到黑名单的生效日期以及持续时间,在规定时间内,黑名单中人员或公司不能加入制药行业。 第四类、其它 1、药品登记 1.1 、National Drug Code Directory 包括
亦有483后不开警告信直接导致禁令的情况。 Debarment List 排除清单 该清单包括了所有不允许生产销往美国的药品的公司。排除清单是公开的。 Court - Consent Decree 法院---法令。
将停止颁发一个或多个药品的批准。停审申报资料。 Import Stop / FDA Import Alert 进口中止/FDA进口禁令 The company's product (or products) may no longer be imported into the United States. The goods remain at customs. 公司的产...
Generic Drug Industry Scandal: Convicted FDA Reviewer Is Freed From DebarmentBrenda Sandburg
1404 政府范围的排除与暂停(非获得) GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) 1405 对无毒品工作场所的政府范围的要求(财政援助) GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) 1406-1499 [预留的] [Reserved]
1404 政府范围的排除与暂停(非获得) GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) 1405 对无毒品工作场所的政府范围的要求(财政援助) GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)&nbs 更多 收起服务流程 官方收费 基础法规 时间分布 相关服务服务流程资料添加中... 官方...
“that the Agency enhance its debarment and disqualification procedures.” The latter recommendation was made consistent with the findings of a2009 GAO reportcritical of FDAs oversight of clinical investigators – see our previous posthere. FDA issued the letter in response to a March 4, 2010 Gover...
1404 政府范围的排除与暂停(非获得) GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) 1405 对无毒品工作场所的政府范围的要求(财政援助) GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)&nbs 更多 收起服务流程 官方收费 基础法规 时间分布 相关服务服务流程资料添加中... 官方...
Applications will not be processed. Import Stop / FDA Import Alert The company's product (or products) may no longer be imported into the United States. The goods remain at customs. Debarment List This list comprises all persons who are not allowed to produce pharmaceutical products for the ...
drug/biologic (21 U.S.C. 355 (b)(2) or (j)(2)(A)) 15. Establishment description (21 CFR Part 600, if applicable) 16. Debarment certification (FD&C Act 306 (k)(1)) 17. Field copy certification (21 CFR 314.50 (l)(3)) 18. User Fee Cover Sheet (PDUFA Form FDA 3397, GDUFA ...