Simplifying Global Compliance
Due to the holidays, Clinical Trial Advisor
will not be published Dec. 19. The next issue will be published on Jan. 2, 2014. Read More
In the latest initiative to clean up its troubled clinical trial industry, the Indian government is requiring investigators to video record the informed consent process for each subject in clinical studies. Read More
The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More
The FDA and Vanda failed to agree on a prespecified primary endpoint for the new sleep disorder drug, tasimelteon, but that didn’t derail the company’s NDA. Read More
The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have agreed to work together to help regulators and drug sponsors make the most of clinical and postmarket health data. Read More
New technology and anxiety over expiring patents have driven pharma to triple clinical development of large molecule and biologic drugs over the past decade, says an industry expert. Read More
The biggest hurdle when trial investigators and staff are trying to build a good relationship with a study participant is managing their expectations, experts say. But there are some basic tips sites can use to overcome those hurdles. Read More
With EU lawmakers and the European Council expected to reach a compromise on clinical trial regulations before Christmas, pharma, researchers and patient groups are asking for assurance that timelines for trial data submissions are predictable and no longer than timelines currently in force. Read More
While developers of next-generation heart drugs known as PCSK9 inhibitors will need to present data showing their effectiveness at lowering cholesterol, blood pressure and inflammation, they will not be required to show reduced heart attack or stroke, according to the FDA. Read More
In vitro diagnostics products meant for research or investigational use used commercially without appropriate approvals may be considered adulterated and misbranded, an FDA final guidance says. Read More
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