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The Clinical Decision Support Coalition calls on FDA to develop a new form of case study guidance to provide the agency view on a ...[ Price : $8.95]
Aerie Pharmaceuticals files an NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, a novel once-daily eye drop designed to l...[ Price : $8.95]
FDA alerts women and doctors to risks associated with tests marketed as ovarian cancer screens.[ Price : $8.95]
FDA clears an Invendo Medical 510(k) for the invendoscopy E200 System, which includes the invendoscope SC200, a sterile, single-us...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on requests for c...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on the information collection requirements for regulations on human cells, tissues, an...[ Price : $8.95]
Federal Register Notice: FDA issues an Emergency Use Authorization for an in vitro diagnostic device for detecting Zika virus.[ Price : $8.95]
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for first-line treatme...