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the pilot work of real-world data application in the clinical trial of drugs and devices
Time of Update: 2023-01-01
On December 7, 2022, the State Food and Drug Administration and the Hainan Provincial Government jointly held the fourth meeting of the 2022 Leading Group for the Pilot Work of Clinical Real-World Da
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Asieris' diagnostic and postoperative monitoring drug Hikewei was approved by CDE to be included in the clinical real-world data application pilot
Time of Update: 2022-04-26
SH), a global innovative company focusing on urogenital tumors, recently announced that the Hainan Provincial Food and Drug Administration, based on the opinions of the Center for Drug Evaluation (CDE) of the State Drug Administration of China, has The drug Hexvix for bladder cancer diagnosis and postoperative monitoring was included in the pilot application of real-world data in drug clinical practice .
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Express is based on real-world data, FDA approves immunosuppressive agents to expand the scope of application
Time of Update: 2021-08-07
The FDA press release noted that this approval marks the first time an immunosuppressive drug has been approved to prevent rejection in adult and pediatric patients undergoing lung transplantation .
Reference materials: [1] FDA Approves New Use of Transplant Drug Based on Real-World Evidence.
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FDA approves immunosuppressive agents based on real-world data to expand the scope of application
Time of Update: 2021-07-29
The FDA press release noted that this approval marks the first time an immunosuppressive drug has been approved to prevent rejection in adult and pediatric patients undergoing lung transplantation .
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The pilot product is conditionally approved for the clinical real-world data application of marketed drugs to open a new stage
Time of Update: 2021-04-19
The Center for Drug Evaluation takes the support of real-world research as a key point to promote regulatory scientific research, solidly compiles guiding principles, and scientifically conducts technical reviews; Hainan Provincial Food and Drug Administration performs territorial regulatory responsibilities, and coordinates and solves the practical difficulties encountered by companies; companies are rigorously designed The research plan and strict compliance with the research norms.
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attention to the real world to add preservatives potential risks
Time of Update: 2021-01-29
1 Industry shift speed up, clinical use of the proportion of sharp rise with a new round of scientific and technological revolution and industrial changes continue to deepen and accelerate, the past people respected the "noble" drugs gradually civilian, and single anti-drug specificity is high, toxic side effects are small, for a variety of malignant tumors have significant efficacy, greatly improve the clinical access of biological drugs.
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Fourtean drug varieties entered the clinical real-world data application pilot in Boao Lecheng Pre-City District
Time of Update: 2021-01-14
" Hainan clinical real-world data application pilot work, help to further promote the international advanced pharmaceutical products to accelerate access to the Chinese market, for domestic patients to provide more choices for drug use, but also to enable more Chinese patients to benefit from innovative drugs and medical devices.
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CDE: Drug real-world data application pilot accelerated
Time of Update: 2020-11-05
he pointed out that the Lecheng Advance Zone is the first zone of Hainan Free Trade Port, and the implementation of the pilot construction of real-world data application is of great significance for deepening the reform of the drug review system and better meeting the medical needs of the people.