guidance名— 指引名 · 指南名 guidance— 教导 · 训迪 for sb— 为人 查看更多用例•查看其他译文 查看其他译文 © Linguee 词典, 2024 ▾ 外部资源(未审查的) On the other hand, in the US, the biotechnologyindustry,ratherthanFDA,isresponsibleformonitoring the labelling ...
美国FDA更新食品接触回收塑料法规 2021年7月,美国食品和药品管理局(FDA)更新食品接触回收塑料指南文件---Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)。该指南文件于2006年8月*次发布,为企业提供了评估食品接触回收塑料安全与否的建议及方案。本次更新主要加入了美国《...
Guidance for Industry[1] 行业指南 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the...
This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the ...
If you need clarification on the applicability of this guidance to a specific clinical trial, contact the appropriate FDA Center with responsibility for review of the IND. 本指南适用于1期研究性药物,无论它们是在小型或大型环境中生产,因为1期临床试验(21 CFR 312.21(a))通常是为了评估特定药物或生物制...
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays Document issued on January 10, 2007 For questions regarding this document contact Nina Hunter at 301-796-6171 or by email atnina.hunter@fda.hhs.gov....
(FDA)多个中心或办公室联合发布了题为《良好实验室规范(GLP)研究报告翻译:问题与解答行业指南(草案)》(Translation of Good Laboratory Practice Study Reports: Questions and Answers Guidance for Industry(DRAFT GUIDANCE) )的指南就如何翻译符合GLP要求的研究报告提供指导性意见,以确保GLP研究报告翻译的规范性、清晰...
FDA Issues Guidances For Industry To Improve The Safety Of Food, Feed And DrugsmntCancer
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems Document issued on July 27, 2006 For questions regarding this document, contact Elizabeth Stafford at 301-796-6184 or by e-mail at elizabeth.stafford@fda.hhs.gov. U.S...
2023年5月,FDA发布了Draft Guidance for Industry, Investigators, and Other Stakeholders Decentrialized Clinical Trials for Drugs, Biological Products, and Devices (以下简称“DCT指引(征求意见稿)”),从多个实践操作的角度提出了对去中心化临床试验(“DCT”)实施的建议。这是继FDA于2021年12月发布对行业、研究...