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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
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 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 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
Lawmakers are asking the White House Office of Management and Budget (OMB) to wrap up its review of a proposed rule that would require electronic package inserts for prescription drugs and biologics, saying the implementation blueprint is long overdue. Read More
Companies producing vaccines in the EU to protect against annual flu strains will not need to conduct pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season. Read More
To discourage GMP scofflaws, the European Medicines Agency is now publicly naming drugmakers that aren’t in line with current good manufacturing practices. Read More
Unresolved investigations into bottling and packaging operations and insect problems have landed one of Sandoz’s U.S. facilities a Form 483. During an October inspection of Sandoz’s Broomfield, Colo., facility, investigators found spiders, centipedes and moths. Read More