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Advanced Medical Technology Association says FDA should clarify that a three-year compliance date exception allowed under the Uniq...[ Price : $8.95]
FDA approves a McGuff Pharmaceuticals ANDA for hydroxyprogesterone caproate injection USP, 250 mg/mL (1.25 g/5 mL vials), a generi...[ Price : $8.95]
Bristol-Myers Squibb agrees to settle charges that a joint venture in China made cash payments and provided other benefits to heal...[ Price : $8.95]
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...