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Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
An FDA draft guidance that would require informed consent documents to include detailed descriptions of treatment alternatives to experimental drugs would confuse patients so much that recruiting subjects for clinical trials will become nearly impossible, drugmakers argue. Read More
The FDA has again rejected Amarin’s appeal for the agency to reinstate a special protocol assessment (SPA) on a phase III study of its triglyceride drug Vascepa, a move that casts doubt on the drugmaker’s ability to expand its indication on the fish oil-based product. Read More
Regulatory challenges in interpreting data from multiregional clinical trials have prompted the International Conference on Harmonisation to prepare a guideline on trial planning and design according to a recent concept paper. Read More
Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Aug. 20. Read More
Testing an experimental Ebola drug during an outbreak such as the one currently going strong in West Africa poses a number of ethical issues, clinical trials experts say. Read More
CDER Director Janet Woodcock is calling on industry to collaborate in the development and verification of new biomarkers, which the agency says can improve clinical trial efficiency but so far have been underused. Read More
A public-private partnership in the EU plans to spend $4.5 billion over the next decade to boost, by 30 percent, the success of clinical trials on high-priority drugs. Read More
Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Wednesday. Read More
Implantable heart devices improve the chances of survival across racial groups, a study published in Tuesday’s Journal of the American College of Cardiologists concludes. Read More