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The FDA needs to clearly communicate to drugmakers how the agency will use adverse event data gleaned through the expanded access use process, according to a new GAO report. Read More
In a June meeting, the FDA’s pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials. Read More
In developing future clinical trials, sponsors should consider whether the drug will be intended for use as a single agent or as part of a combination therapy, said members of the Oncologic Drug Advisory Committee’s pediatric subcommittee, in a meeting last month. Read More
The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Read More
The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits. Read More
The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials, as part of an agency “innovation initiative” announced July 7 by Commissioner Scott Gottlieb. Read More
The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. Read More
At a meeting on opioids abuse, FDA Commissioner Scott Gottlieb announced that the agency will expand its REMS requirements for extended-release and long-acting opioids to the manufacturers of immediate-release formulations — which account for 90 percent of the opioid painkiller prescriptions written each year in the U.S. Read More
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More