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FDA Launches Pilot Program in Support of Complex Trial Desig

2019-01-23
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The US Food and Drug Administration (FDA) announced a new pilot program Wednesday aimed at encouraging the use of complex innovative trial designs in the development of drugs and biologics. Sponsors selected by FDA based on the criteria for...

What is the ISO9001:2015 Requirements

2019-01-23
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Case of Changchun Changsheng Bio-tech Co's Rabies Vaccine

2019-01-23
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The CNDA Maintaines a Communication with the WHOs Representative Office in China on the Case of Changchun Changsheng Bio-tech Cos Rabies Vaccine Investigation and treatment of the State Councils investigation team on Changchun Changsheng Bi...

China US Conference on the Development and Evaluation of Onc

2019-01-23
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Xu Jinghe,Deputy Commissioner of CNDA,attends the China US Conference on the Development and Evaluation of Oncology Drugs On the morning of July 2,2018,Xu Jinghe,Deputy Commissioner of the National Drug Administration of China(CNDA),attende...

What is the CFDA main responsibilities

2019-01-23
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Main Responsibilities of C hina Food and Drug Adminstration (CFDA) Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (in...

Good manufacturing practice(GMP)

2019-01-23
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Good manufacturing practices ( GMP ) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages , cosmetics , pharm...

FDA Updates Guidance on Electronic Records, Signatures

2019-01-23
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After issuing its controversial Guidance forIndustry Part 11, Electronic Records;Electronic Signatures Scope and Application 1 20 years ago, the FDA struggled with consistentenforcement of the guidance. At the time, industrycountered with f...

Implementing Contamination Control for cleanrooms

2019-01-23
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A CLEANROOM CAN BE DEFINED as a high-tech, controlled environment where the concentration of airborne particles, humidity, and temperature are all controlled to parameters specified by the ISO 14644. As science progresses, the demand for cl...

What is Sustainable Packaging?

2019-01-23
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To understand what sustainable packaging is all about, we must turn to an organization called GreenBlue. This non-profit has taken a leadership role in promoting, among other things, the use of sustainable packaging materials internationall...

Laser Particle Counter Known Well Through ISO14644-2015 Stan

2019-01-23
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ISO 14644-2015 New Version ISO14644 consists of the following parts: Part 1: Classification of air cleanliness by particle concentration Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle...