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FDA releases a revised draft guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.[ Price : $8.95]
FDA clears a Koag 510(k) for its Vascette HP device, a topical vascular closure pad that uses a proprietary, plant-derived hemosta...[ Price : $8.95]
After 38 years as National Institute of Allergy and Infectious Diseases (NIAID) director, Anthony Fauci says he will be stepping d...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Devices: Current Good Manufact...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Center for Devices and Radiological Health ...[ Price : $8.95]
A new research article by FDA and European regulators finds their good clinical practice inspection processes to be equivalent, wh...[ Price : $8.95]
FDA classifies as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronizat...[ Price : $8.95]
A new FDA report on Covid-19 activities notes that the agency is initiating a new inspection planning system that will be more eff...