FDA 的监管事务办公室 (ORA,The Office of Regulatory Affairs) 负责对受监管公司的检查。在这些检查期间(可以是提前通知的,或突击的),如果 ORA 调查员观察到他们认为可能不合规的情况,他们会在 FDA 483 表格中列出观察结果,并将其提交给公司管理层。FDA 调查员接受过专门培训,可以确...
FDA 的监管事务办公室 (ORA,The Office of Regulatory Affairs) 负责对受监管公司的检查。在这些检查期间(可以是提前通知的,或突击的),如果 ORA 调查员观察到他们认为可能不合规的情况,他们会在 FDA 483 表格中列出观察结果,并将其提交给公司管理层。FDA 调查员接受过专门培训,可以确保在FDA 483 表中清晰、具体...
50、ateningdiseases.Americandruglawhascomequitefarsincetheearly1900s.Today,theFDAcontinuestoworkwithCongressandthepharmaceuticalindustrytoregulateandevaluatenewandexistingdrug,biologic,anddeviceproducts.TheoverridingregulatorychallengethattheFDAwillfacewillbetokeepcurrent,throughregulationandpolicy,futu ...
Some deadlines have passed. Others are approaching fast. The European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) increase the scope and stringency of regulatory expectations for those marketing devices and some diagnostics in the EU. ...
Medical Device Safety Expert FormerFDA.com employs clinical and regulatory experts who are former FDA employees and are highly experienced in analyzing device safety data from the FDA (including the MAUDE database) as well as other reliable sources. ...
FDA Medical Device Regulation: A Guide for Prescription Drugs, Medical Devices, and Biologics FDA Regulatory AffairsPrescription DrugsMedical DevicesBiologicsDrug DevelopmentClinical TrialsINDsCTDFor dichotomous data based on unequal frequencies, the formulae... B Sall - FDA Regulatory Affairs 被引量: 16...
Biotech Consultant LLC provides consulting services in the scientific and regulatory aspects of a wide range of medical devices with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, and microarrays), medical device
FDA 的监管事务办公室 (ORA,The Office of Regulatory Affairs) 负责对受监管公司的检查。在这些检查期间(可以是提前通知的,或突击的),如果 ORA 调查员观察到他们认为可能不合规的情况,他们会在 FDA 483 表格中列出观察结果,并将其提交给公司管理层。FDA 调查员接受过专门培训,可以确保在FDA 483 表中清晰、具体...
The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaborations between the drug and device regulators. ...
监管事务办公室Office of Regulatory Affairs(ORA) (职位:准专员Associate Commissioner) ●资源管理办公室 Office of Resource Management ●强制执法办公室 Office of Enforcement ●地区性运行办公室 Office of Regional Operations ●犯罪调查办公室 Office of Criminal Investigations ...