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The European Medicines Agency says it’s no longer acceptable for sponsors to conduct placebo-controlled clinical trials when developing monotherapy drugs for lipid disorders. Read More
Chinese authorities are urging vaccine manufacturers to implement better adverse event reporting procedures during clinical research and to adhere to reporting timelines. Read More
Videotapes of patients giving informed consent to participate in clinical trials must show the investigator explaining the study protocol in language the subject can understand, according to a draft guideline by India’s Central Drugs Standard Control Organization. Read More
The FDA’s Center for Devices and Radiological Health is working on ways to permit sponsors to use more adult clinical trial data in proving the safety and effectiveness of pediatric medical devices. Read More
The FDA’s breakthrough therapy program is proving its potential to advance new drugs and biologics targeting unmet needs, a new Tufts University report says. But industry interest in the year-old program may wane if the approval times for breakthrough drugs don’t improve. Read More
Sponsors of both over-the-counter and prescription point-of-care blood glucose tests should design trials that replicate real-world usage conditions, the FDA says. Read More
Research has shown that failure to meet recruitment goals extends a clinical trial’s duration by about six weeks in 75 percent of cases. Now a new study suggests a possible solution. The answer: big data. Read More
Drugmakers are encouraged to work together to get agency qualification for drug development tools, which can be used to aid in development and review of multiple companies’ drugs, according to an FDA final guidance. Read More
Sponsors conducting clinical trials in India must fully inform study patients about potential payments resulting from adverse events during videotaped informed consent sessions, a draft guideline says. Read More
The European Medicines Agency says it is no longer acceptable for sponsors to conduct placebo-controlled clinical trials when developing monotherapy drugs for lipid disorders. Read More