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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 issues a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop...[ Price : $8.95]
provals managing director Steven Cohen lists the many benefits of FDA advisory committees even as the agency has reduced its use o...[ Price : $8.95]
The CDER Office of Prescription Drug Promotion says a Daiichi Sankyo promotional video patient testimonial for its Turalio mislead...[ Price : $8.95]
Former FDA associate commissioner Peter Pitts says CDER director Richard Pazdurs decision to abruptly retire was motivated by grow...[ Price : $8.95]
Capricor Therapeutics says Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrop...