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JPM2024: Impact of China’s HGR Rules on clinical trials and scientific studies involving China sites

Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...more

Life Sciences and Health Care Horizons - 2019

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs

On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment: (1) Conditional Approval for Urgently Needed Drugs Technical Guidance (the “Draft Conditional Approval...more

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