美国当地时间2024年2月20日, FDA发布了一则关于“上市前提交的实验室检测数据中存在欺诈和不可靠:美国食品药品监督管理局提醒医疗器械制造商审查第三方实验室生成的数据”的公告。 https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-f...
https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device ASCA实验室网址: https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/asca-accredited-testing-laboratories 美国FDA开始仔细...
insupportofapprovednewdrugapplications(NDAs)andabbreviatednewdrugapplications (ANDAs).1 1.ORA应使用此合规计划对生产设施进行批准后检查,以支持已批准的新药申请(N DA)和缩写新药申请(ANDA)。1 Forreportingbiologicalpostapprovalinspections,usethePAC56843underthiscompliance ...
Specification: The quality standards (., tests, analytical procedures, and acceptance criteria) provided in an approved application to confirm the quality of the drug substances, drug products, intermediates, raw materials, reagents, and other components including container closure systems, and in-...
Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions 对已批准的组分、药品容器和密封部件经长期存放或暴露于不利条件后,执行复检或复验。 6. To review and approve or reject allthings CGMP ...
Also, you should compare the methods being used for incubation to determine if they conform to those listed in approved or pending applications.应对样品的培养时间进行评价,有关这个方面的规定最近刚被确实。USP规定无菌检测样品至少要培养7天,有人建议将时间延长至14天。样品培养时间的长短应该由产品的性能和...
(FDA)has approved the company’s Premarket Approval(PMA)supplement application for its oncoReveal™ CDx pan-cancer solid tumor in vitro diagnostic(IVD).The approval expands the indication of oncoReveal™ Dx from EGFR & KRAS thera...
Contains Nonbinding Recommendations Draft - Not for Implementation 1 2 Draft Guidance for Industry, Food and 3 Drug Administration Staff, and Clinical 4 Laboratories 5 6 7 Framework for Regulatory Oversight of 8 Laboratory Developed Tests (LDTs) 9 10 DRAFT GUIDANCE 11 12 13 This guidance document...
D.UpdatingApprovedDrugProductSpecifications 更新已批准药品质量标准 APPENDIX:CASESTUDYEXAMPLESOFMICROBIOLOGICALCONTAMINATIONOFNSDPRODUCTS;IMPACTONPRODUCTQUALITYANDMANUFACTURINGPROCESS 附录:案例研究:NSD产品的微生物污染示例;对产品质量和生产工艺的影响 MicrobiologicalQualityConsiderationsinNon-sterileDrugManufacturingGuidancefor...
5. Preserve the comments and signatures of all production and quality control personnel who conducted the investigation and approved any reprocessed material after additional testing D. INVESTIGATION DOCUMENTATION Analyst's mistakes, such as undetected calculation errors, should be specified with ...