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Sponsors may be asked to provide the European Medicines Agency with additional data from failed trials to hone in on subpopulations where the treatment may be effective. Read More
The Scottish Medicines Consortium plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
Medical centers that opt to create a clinical research department should take a bottom up approach and get input from all trial stakeholders to minimize risks. Read More
Drugmakers are urging the FDA to publish extensive guidance on even the most basic issues related to clinical trial diversity as the agency steps up its efforts to increase diversity in clinical trial subject populations. Read More
Sponsors should use Extensible Markup Language (XML), not Standard Generalized Markup Language (SGML) when transmitting reports about patient reactions in clinical trials, according to an FDA final guidance. Read More
Sponsors of new drugs and biologics for chronic pain may have to submit more safety data than they would to support acute pain candidates, an FDA draft guidance says. Read More
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
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