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’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific ...
美国FDA指导原则 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document Fecal Calprotectin Immunological Test Systems.docx,Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Imm
CenterforVeterinaryMedicine (CVM) November2016 PharmaceuticalQuality/ManufacturingStandards(CGMP) FDA行业指南:药品委托生产安排:质量协议翻译:Julia FDAGuidance forIndustry: ContractManufacturing ArrangementsforDrugs:QualityAgreementsPage2/21 GuidanceforIndustry Additionalcopiesareavailablefrom: OfficeofCommunications,Divisi...
FDA：Guidance for Industry Guidance for Industry 工业界指南 Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice 无菌工艺生产的灭菌药品 CGMP U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)Cent...
The guidance is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices. 3 FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic...
Revision 1 Drug Master Files Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone...
3-Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024 (Updated January 2024) 作者简介:zhulikou431,高级工程师、PDA会员、ISPE会员、ECA会员、PQRI会员、资深无菌GMP专家,在无菌工艺开发和验证、药品研发和...
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《文书缩减法案》的相关信息以及进行...
GuidanceforIndustry工业界指南SterileDrugProductsProducedbyAsepticProcessing—CurrentGoodManufacturingPractice无菌工艺生产的灭菌药品C..