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Sponsors should gather supportive data from two definitive clinical trials to establish efficacy for drugs proposed to treat chronic fatigue syndrome/myalgic encephalomyelitis, the FDA says. Read More
The European Medicines Agency (EMA) is calling on EU makers of seasonal influenza vaccines to develop enhanced safety signal monitoring systems that identify increases in allergic reactions, moving away from systems that simply check for specific batch deviations. Read More
India’s Ministry of Health and Family Welfare has begun publishing data about compensation paid in clinical trial-related deaths, with the first wave of data covering 2010 into 2013. Read More
The FDA’s decision to make growth in U.S. clinical trials a high priority is leading to new guidances, shortened approval waits on IDEs and a new position dedicated to handling device trial issues. Read More
The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More
India’s Ministry of Health and Family Welfare on Friday began releasing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial, with the first wave of published data focusing on payouts for trial-related deaths between 2010 and 2013. Read More
Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
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