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GlaxoSmithKline (GSK) is on track to move as much as 30 percent of its human clinical drug trials to low-cost countries, according to the drugmaker’s top executive.
The Medicare drug benefit will likely stoke pressure for new legislation requiring clinical studies comparing new drug products to those already on the market, according to a former top FDA official who opposes such a mandate in the preapproval stage.
Democrats in the House and Senate have introduced legislation that would mandate registration of clinical trials for human drugs, biologics and medical devices at an existing NIH online database, as well as restrict the use of study data in promotional materials for sponsors that don't register their trials.
The FDA will not, for the most part, enforce 21 CFR Part 11 rules related to computerized systems used in clinical trials, according to a draft guidance issued Sept. 29.
The FDA will impose a partial or complete clinical hold on research studies involving human drugs and biologics in cases where a clinical investigator has committed serious violations of FDA regulations or submitted false data to the agency or trial sponsor.
The FDA is on the verge of releasing a new guidance document that addresses the use of computerized systems in clinical trials, a move that could help the agency establish a consistent, risk-based approach to Part 11 for all segments of the pharmaceutical industry.
A guidance document released by the FDA instructs clinical
trial sponsors on when and how to request that the agency engage
an independent consultant to participate in reviewing clinical studies, which serve as the primary basis of efficacy claims.
The FDA has released a guidance document that instructs clinical trial sponsors on when and how to request that the agency engage an independent consultant to participate in reviewing clinical studies, which serve as the primary basis of efficacy claims.
In response to the growing controversy over the suppression of negative clinical trial data, Eli Lilly has announced it will disclose all clinical trial results for the drugs its sells on a public registry, beginning the fourth quarter of this year.