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An independent panel commissioned last summer to review Guidant's handling of its failed heart devices said the company should form an external committee of experts to serve as advisers.
The FDA is encouraging institutions to consider using centralized institutional review boards (IRBs) to coordinate the actions of multiple IRBs in multicenter clinical trials, according to new industry guidance.
New FDA guidance argues that sponsors of products that combine two or more previously marketed drugs or biologics may be able to rely on existing clinical and nonclinical safety data before proceeding with clinical trials of the proposed combination therapy.
The FDA is encouraging the development of centralized institutional review boards (IRBs) to coordinate the actions of multiple IRBs in multicenter clinical research, according to new guidance.
The FDA unveiled its long-awaited Critical Path Opportunities List March 16, focusing on projects that will advance the use of biomarkers and streamline clinical trials.
The FDA wants centralized institutional review boards (IRBs) to coordinate the actions of multiple IRBs in multicenter clinical research, according to new industry guidance.
Sponsors of products that combine two or more previously marketed drugs or biologics may be able to rely on existing clinical and nonclinical safety data before proceeding with clinical trials of the proposed combination therapy, according to a new FDA guidance.
The FDA will not enforce existing recordkeeping requirements for the distribution of prescription drugs to free clinics due to concerns about potential financial burdens, according to revised agency guidance.