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A dozen former FDA commissioners warn that sweeping internal directives proposed by CBER director Vinay Prasad would undermine evi...[ 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]
FDA warns Provo, UT-based Rhyz Analytical Labs about CGMP violations in its work as a contract testing laboratory.[ Price : $8.95]
FDA warns Conway, AR-based Turbare Manufacturing about CGMP and other violations in its work as an outsourcing facility producing ...[ Price : $8.95]
FDA publishes a guidance to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related informa...[ Price : $8.95]
A Washington, DC, federal judge rules that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its dru...