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FDA says it will speed up generic drug approvals by allowing marketing on the basis of submitted draft, rather than final printed ...[ Price : $8.95]
FDA issues St. Jude Medical a Warning Letter citing its Atlantia, GA manufacturing facility for GMP violations related to the manu...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information in the Public Health Service guideline on xeno...[ Price : $8.95]
Federal Register Notice: FDA requests comments on the abuse potential, etc. of 10 drug substances to prepare a response to the Wor...[ Price : $8.95]
FDA says it has received recent reports about the reduced leaflet motion in some bioprosthetic aortic valves, including both trans...[ Price : $8.95]
FDA orders the three makers of duodenoscopes to conduct postmarket surveillance studies to better understand how the devices are r...[ Price : $8.95]
An FTC brief to the Third Circuit Court of Appeals calls into question brand name drug makers product-hopping, whereby companies m...[ Price : $8.95]
FDA accepts a Sandoz BLA (351(k) pathway) for a proposed biosimilar to Amgens Enbrel (etanercept), indicated for treating a range ...