Simplifying Global Compliance
The FDA wants IND sponsors to stop routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
The level of detail required in sponsor declarations regarding ongoing research should be proportionate to the risk associated with the research being conducted, the UK’s Health Research Authority 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
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
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
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
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
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
While EU regulators push ahead with a trial transparency initiative, the Institute of Medicine has stepped into the debate, seeking feedback on a wide range of proposals to encourage clinical data sharing in the U.S. Read More
The FDA has warned a clinical investigator that half of the patients in her study are ineligible to participate based on the study protocol. Read More
Johnson & Johnson unveiled a first-of-kind clinical trial data-sharing plan that it hopes will become a model for industry transparency initiatives: rather than provide direct access to trial data, sponsors could contract with third parties to serve as gatekeeper and approve data access requests. Read More
A new data standard being proposed by the Clinical Data Interchange Standard Consortium could give sponsors and FDA reviewers greater flexibility to analyze data, if adopted by the agency for drug review applications. Read More
The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. 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
Vaccine trial sponsors should report study-related fatalities within seven days of an event and submit follow-up reports by eight days later, a recent China Food and Drug Administration guideline says. Read More
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2014. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing