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ZymoGenetics said the FDA has informed the company that it will not be required to conduct an additional Phase III clinical trial of its recombinant human Thrombin (rhThrombin), which aids in controlling bleeding during surgery.
Industry involvement in breast cancer trials may affect study design, focus and results, according to an article published in the online version of the journal Cancer.
Listing clinical trials with a public registry can increase public confidence in the pharmaceutical industry and help patient recruitment efforts, according to an expert speaking at a recent industry conference.
Efficient site selection by clinical trial sponsors can help avoid costly delays in patient recruitment, but many drug and device companies are failing to take the necessary steps.
VaxGen said that HHS has terminated for default the company’s $877.5 million contract to provide 75 million doses of a modern anthrax vaccine for civilian biodefense.
The FDA's Blood Products Advisory Committee recommended recently that the agency not lift its clinical hold on a Navy clinical trial of Biopure's blood substitute, Hemopure.