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Merck and Lundbeck announced they are stopping their entire development program for gaboxadol, an investigational new insomnia drug, in the midst of a Phase III clinical trial.
The FDA’s Chicago district office and the Society of Clinical Research Associates are sponsoring a workshop on FDA clinical trial statutory and regulatory requirements May 16–17 in Oak Brook, Ill.
Amgen’s clinical program to expand Vectibix’s use as a first- and second-line treatment for metastatic colorectal cancer is not affected by the discontinuation of the Avastin-Vectibix combination trial, which was halted due to efficacy and safety concerns.
Drug manufacturers choosing to submit applications to CDER electronically — as opposed to on paper — will have to use a particular electronic format called the electronic common technical document (eCTD) starting Jan. 1, 2008, an FDA official said.
The FDA has recommended that manufacturers of sleep agents initiate clinical studies to determine the incidences of sleep-driving and other complex sleep behaviors that have been observed in postmarketing reports, the agency said.
Details on conducting clinical trials under the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) are laid out in a new consultation paper released by the two countries’ current regulatory authorities.
A major study of carotid stenting has reproduced results of a previous large study, showing the treatment is safe and effective for preventing stroke in high-risk patients, the Society of Interventional Radiology announced.
A recent study concludes that financial conflicts of interest are common in orthopaedic research, with researchers demonstrating a greater tendency to report positive findings about devices if they earned royalties, held stock options, served as consultants or were employees of device firms.
Details on conducting clinical trials under the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) are laid out in a new consultation paper released by the two countries’ current regulatory authorities.