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FDA names physicianepidemiologist Tracy Beth Heg as CDER acting director, replacing director Richard Pazdur, who submitted his ret...[ Price : $8.95]
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]
The House approves legislation reauthorizing the FDA Pediatric Rare Disease Priority Review Voucher program and giving the agency ...[ Price : $8.95]
FDA publishes a draft guidance on streamlined nonclinical safety studies for monoclonal antibodies.[ Price : $8.95]
FDA warns Provo, UT-based Rhyz Analytical Labs about CGMP violations in its work as a contract testing laboratory.