申请FDA DMF注册时,使用的主要表格是FDA Form 356h。该表格适用于药品原料、添加剂和其他相关化学品的注册。具体步骤如下: FDA Form 356h:这是FDA批准药品和化学品的标准申请表格,用于提交DMF申请。表格中要求提供企业信息、药品或化学品的详细描述、生产过程、质量控制信息等。 2. 填写FDA Form 356h的关键要素 ...
Refer to the instruction sheet (Form FDA 356h Supplement) for more information. Establishment Name Address 1 (Street address, P.O. box, company name c/o) Registration (FEI) Number Address 2 (Apartment, suite, unit, building, floor, etc.) MF Number City State/Province/Region Estab...
FDA 356h form 来自 Semantic Scholar 喜欢 0 阅读量: 258 作者: G Nahler 摘要:Form used in the USA for application to market a new drug for human use or an antibiotic drug for human use; → see also food and drug administration, new drug application....
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./icon/react-icon/IconFaceMehFill/index.js 1.04 kB ./icon/react-icon/IconFaceSmileFill/index.js 1.11 kB ./icon/react-icon/IconFile/index.js 925 B ./icon/react-icon/IconFileAudio/index.js 992 B ./icon/react-icon/IconFileImage/index.js 961 B ./icon/react-icon/IconFilePdf/index.js ...
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FORM FDA 356h-DRUG OR BIOLOGIC FOR HUMAN USE 热度: DEPARTMENTOFHEALTHANDHUMANSERVICES FOODANDDRUGADMINISTRATION STATEMENTOFINVESTIGATOR (TITLE21,CODEOFFEDERALREGULATIONS(CFR)PART312) (Seeinstructionsonreverseside.) FormApproved:OMBNo.0910-0014
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