(Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products) 背景介绍 先前FDA于2023年10月13日发布了一份新的行业指南草案:《局部眼用药品的质量考量》,该指南草案阐明了眼内及眼周局部给药的眼用药品的重要质量考虑因素,涉及眼用药品的多种剂型,包括液体制剂(外用溶液、混悬液、乳剂)、凝胶...
可用于确定药品的有效期限,以及支持说明书中声称的开封后储存条件。 参考文献:FDA. Guidance for Industry:Quality Considerations for Topical Ophthalmic Drug Products.2023.12
FDA is announcing a new draft guidance for industry, Quality Considerations for Topical Ophthalmic Drug Products. Ophthalmic drug products refer to any FDA-regulated drug products that are used for topical delivery around the eye such as solution...
美国FDA 指导原则 符合21 CFR第4部分工业指南的某些眼科产品政策 英文原版.pdf,Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry This guidance is for immediate implementation. FDA is issuing this guidance for i
(b)(4) effectiveness testing for benzalkonium chloride containing ophthalmic products 含苯扎氯铵的眼科产品的(b)(4)有效性检测 See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements...
Food and Drug Administration's (FDA) release of a draft guidance for minimally invasive glaucoma surgery (MIGS) equipment. Topics covered include recommendations on study design and duration, safety consideration and clinical end-points and FDA Division of Ophthalmic Device Evaluation director Malvina ...
As described in the guidance for industry ContainerClosure Systems for Packaging Human Drugs and Biologics (July 1999), the capcolor of ophthalmic drug products should follow AAO color codes, or theapplicant should provide adequate justification for deviations from the AAOcolor coding system. For the...
As described in the guidance for industry ContainerClosure Systems for Packaging Human Drugs and Biologics (July 1999), the capcolor of ophthalmic drug products should follow AAO color codes, or theapplicant should provide adequate justification for deviations from the AAOcolor coding system. For the...
Q2:Howwillthisguidanceaffectthe’sEmergencynforAIDSRelief (PEPFAR)andpositronemissiontomography(PET)ANDAs? A2:Forchemistry,manufacturing,andcontrols(CMC)information,PEPFAR ANDAsshouldfollowtheguidanceforindustryonFixedDose Combinations,Co-PackagedDrugProducts,andSingle-EntityVersionsof ...
Itdoes,haJever, offerguidancem acceptablea~caches tomeetingregulatoryrequiremnts. Different approaches naybe fol.lowed,buttheapplicautis encouraged to discuss significant variations in advance with m reviewers to preclude expmding time andeffortinpreparinga submissim that FDA may later determine to be ...