Garth Boehm, Lixin Yao, Liang Han, Qiang ZhengAbstract The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the p

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Durin

The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. The Coronavirus Treatment Accel

On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Dr

The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due t

On June 4, 2020, the U.S. Food and Drug Administration (FDA) updated the Compliance Program Guidance Manual (CPGM) to include a program for “Inspections of CDER-led or CDRH-led Combination Products.

固体制剂车间D级洁净区，干燥器补集袋、烘箱盘子布、工作服洗涤后是否需要有消毒一步？如何消毒。洗衣机是否需要定期消毒？如何进行

On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,”

Earlier today, FDA published its finalized Data Integrity Guidance.  The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and updates the agency

On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take pl

The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system.  It ha

On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to bre

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今年四月份公司生产的三批工艺验证批胶囊其中一批成品溶出度结果偏低（该批溶出度结果单值未超下限但普遍偏低，且均值相比同工艺验证另外两批

晚上不用，为节省能源夜班关闭，白天用的时候再开起来，需要有什么检测吗？

葡萄糖注射液考察过程中5羟甲基糠醛升高的原理

WHO 3月30日发布的数据可靠性指南中 4.10 中 database build, data collection, data review, blinded data, randomization 中 blinded data 如何理解？

在细胞培养过程中，如何追溯整个生命周期？不同的细胞是由同一个细胞分化而来，如何溯源并做到区分？

设备使用一定年限后如何跟踪管理？

药品储存条件为室温，已完成了常规稳定性考察，如何有理有据的论述低温（2-5℃）条件下的稳定性。