CFDA – Page 2 – media

Ebola vaccine wins approval from regulators

China's top food and drug authority announced on Friday that it has approved the country's first vaccine for Ebola virus disease.
- Source: Chinadaily
- 718
- October 23, 2017
CFDA Ebola New Approvals
China to adjust registration management for drugs and medical devices

To promote the adjustment of industrial structure and technological innovation in the drug and medical device sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017.
- Source: china-briefing
- 1,191
- October 23, 2017
CFDA drug medical device Policy
Novo Nordisk’s new-generation basal insulin Tresiba® approved in China

Novo Nordisk announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.
- Source: Novonordisk
- 542
- September 29, 2017
CFDA diabetes New Approvals Tresiba
Sensus gets Chinese regulatory approval for keloid device

US-based Sensus Healthcare has received approval from the China Food and Drug Administration (CFDA) to commercialise its keloid prevention and treatment device, SRT-100. The tool is designed to deliver a precise and calibrated dose of superficial radiation therapy to ensure a skin deep and safe treatment for patients. The low-dose radiation is intended to destroy keloid-causing non-malignant tumour cells, basal cell carcinoma and squamous cell carcinoma without the use of anaesthesia, risk of infection, scarring or the need for reconstructive plastic surgery. Sensus intends to introduce SRT-100 into the country’s market in the fourth quarter of this year through its Chinese partner Chindex Medical, which is a division of Fosun Pharma International. The device will focus on prevention and treatment of keloids associated with Cesarean sections (C-sections). Sensus Healthcare CEO Joe Sardano said: “CFDA clearance of the SRT-100 for the treatment and prevention of keloids is an important milestone for ...
- Source: Medicaldevice-network
- 450
- July 28, 2017
CFDA Company Insight keloid New Approvals

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