又是数据完整性:CADILA印度厂现行收到FDA警告信
阅119转2刚刚New FDA Inspection Guidance gives the Agency more Power
阅62转0刚刚Major Reorganisation at FDA will affect GMP Inspections
阅80转0刚刚【说图】首仿药的审批和数据保护
阅62转4刚刚FDA publishes new Guidance on Validation of Analytical Methods
阅165转0刚刚What is FDA Readiness exactly?
阅40转0刚刚"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications
阅84转0刚刚Stability Testing of Generics: FDA publishes Q&A Document
阅174转3刚刚New FDA Fees for Drug Master Files published
阅72转0刚刚FDA各种表格介绍
阅2339转18刚刚New Requirements of the FDA on Stability Testing of Generic Drugs
阅114转4刚刚Facts About Current Good Manufacturing Practices (cGMPs)
阅95转1刚刚FDA seeks getting on the List of Third Countries with equivalent GMP Standards
阅47转0刚刚美国仿制药监管要求的新发展
阅60转2刚刚FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL? PCR Mycoplasma De
阅175转2刚刚Marketed Unapproved Drugs-Compliance Policy Guide
阅24转0刚刚Marketed New Drugs Without Approved NDAs and ANDAs
阅130转2刚刚What do the Chemical Type and Review Classification codes stand for?
阅100转0刚刚FDA requires Registration of Manufacturing Facilities until December 2, 2012
阅135转2刚刚US Government Report on Innovation in Pharmaceutical Development
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设计心理学2:与复杂共处