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FDA denies a Fresenius petition asking it not to approve a Keryx sNDA for Auryxia.[ Price : $8.95]
FDA commissioner Scott Gottlieb describes steps the agency is taking to facilitate approval of shared system REMS in an effort to ...[ Price : $8.95]
Federal Register notice: CDER seeks comments on a proposed Analysis Data Reviewers Guide (ADRG) template that was developed under ...[ Price : $8.95]
The Better Business Bureaus National Advertising Division says Synergy Pharmaceuticals declined to participate in a self-regulator...[ Price : $8.95]
A Tufts Center for the Study of Drug Development company survey finds that use of real-world evidence is increasing and will grow ...[ Price : $8.95]
Stericycles third quarter 2017 recall index says medical device recalls fell, while drug recalls increased.[ Price : $8.95]
Federal Register notice: FDA makes available a guidance on Recurrent Herpes Labialis (RHL): Developing Drugs for Treatment and Pre...[ Price : $8.95]
Federal Register notice: FDA submits to OMB a new proposed information collection supporting its Draft Guidance for Industry and R...