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已读[89]
发布： 2014/10/16 09:12:13
By: Alice Welch, Ph.D. If you think the term “government invention” is an oxymoron—well, think again. You may be surprised to learn that many of the breakthrough technologies that shape our lives today are the brainchildren of government researchers—including those … Continue reading →
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已读[92]
发布： 2014/10/16 09:12:05
By: Issam Zineh, PharmD, MPH, FCP, FCCP A key area of new drug development lies in the field of targeted therapies, sometimes called “personalized medicines,” which are drugs tailored to the genetic makeup of individual patients. These drugs are called … Continue reading →
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已读[105]
发布： 2014/10/16 09:11:57
By: Douglas C. Throckmorton, M.D. Hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013. While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem … Continue reading →
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已读[163]
发布： 2014/10/16 09:11:53
By: Margaret A. Hamburg, M.D. Over the last year, a group of senior FDA leaders, under my direction, were tasked to develop plans to modify FDA’s functions and processes in order to address new regulatory challenges. Among these challenges are: … Continue reading →
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已读[102]
发布： 2014/10/16 09:11:49
By: Suzanne Schwartz, M.D., M.B.A. Cyber vulnerabilities – bugs or loopholes in software codes or other unintentional access points – are a real and constant threat to our networked laptops, mobile phones, or tablets. The Heartbleed virus and security breaches … Continue reading →
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已读[143]
发布： 2014/10/16 09:11:44
By: Jean Hu-Primmer, M.S. Scientists love a challenge. And coordinating government agencies, healthcare providers, and numerous additional partners to protect public health in emergency situations is definitely a challenge. FDA’s Medical Countermeasures Initiative (MCMi) is working with federal agencies (through … Continue reading →
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已读[117]
发布： 2014/10/16 09:11:40
By: Carolyn A. Wilson, Ph.D. The word spin might make you think of someone trying to influence your opinion. But in physics, spin refers to an intrinsic property of certain subatomic particles that make some nuclei act like small magnets. … Continue reading →
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已读[115]
发布： 2014/10/16 09:11:36
By: Steve L. Morin R.N., B.S.N. My job in the Food and Drug Administration’s Office of Health and Constituent Affairs (OHCA) is to serve our nation’s patients in two ways: by listening to their concerns regarding FDA’s policy and decision-making … Continue reading →
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已读[140]
发布： 2014/10/16 09:11:32
By: Badrul A. Chowdhury, M.D., Ph.D. Pulmonary fibrosis is a disease in which tissue deep inside the lungs becomes thick, stiff, and scarred, decreasing the lungs’ ability to expand to take in air, and making it difficult to breathe. This … Continue reading →
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已读[116]
发布： 2014/10/16 09:11:25
11 Updated Quarterly Reports
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描述：
通过FDA认证意味着拿到迈向世界的绿卡，而如何通过“FDA认证”与“通过FDA现场检查”是中国医药界心口永远的痛。观念、操作、科学，是我国企业申请“FDA认证“面临的三大挑战。其实FDA并非冷面杀手，世易即将携手美国FDA中国办事处前专职负责审核中国工厂前官员举行系列培训会，帮助中国食品医药企业彻底扫清进入美国市场技术壁垒。 二、专家简介 主讲1：前FDA上海办事处主任Charles A...
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描述：
PPT内容 1. 质量体系基础设施 1）依然在实施中 2）双重标准 3）质量体系理念还未根深蒂固 2. 工艺验证 3. 使用者/工艺需求评估 新系统, 新设备-缺乏足够的支持 4. 监督, 记录活动 5. 偏差和OOS的处理和调查 6. 案例分析
标签： 案例分析
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