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Officials from Kentucky, Maryland, Rhode Island and Virginia testified to a house committee yesterday about the opioid epidemic in their states and asked for more assistance to combat the problem. Read More
The House passed its version of the FDA user fee reauthorization package Wednesday that is expected to bring in $1.42 billion in fiscal 2018, by a voice vote. Read More
The House Appropriations Committee on Wednesday approved a bill by voice vote that would provide a total of $5.2 billion for the FDA in fiscal 2018—$2.6 billion in discretionary spending with the remainder coming from user fees. Read More
The products include HIV antiretroviral therapies and combinations, a treatment for major depressive disorder and a chemotherapy approved in non-small cell lung cancer. Read More
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
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