[ Price : $8.95]
FDA solicits proposals for the CDER Center for Clinical Trial Innovation Bayesian Statistical Analysis demonstration project.[ Price : $8.95]
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters is manufacturing f...[ Price : $8.95]
FDA lifts a partial clinical hold on one of Vanda Pharmaceuticals key tradipitant studies, clearing the company to expand dosing i...[ Price : $8.95]
FDA publishes a guidance on implementing the eCopy submission program for medical devices.[ Price : $8.95]
FDA launches a pilot with the Center for Medicare and Medicaid Innovation to promote access to certain digital health devices cove...[ Price : $8.95]
FDA reportedly is exploring ways PDUFA fees can be adjusted to incentivize companies to hold clinical trials in the U.S. rather th...[ Price : $8.95]
The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.[ Price : $8.95]
CBER director Vinay Prasad addresses a 12/4 investor conference in New York and defends his leadership, and attributing criticism ...