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FDA orders the three makers of duodenoscopes to conduct postmarket surveillance studies to better understand how the devices are r...[ Price : $8.95]
FDA grants Merck accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lun...[ Price : $8.95]
Philadelphia cardiothoracic surgeon Hooman Norchashm meets with CDRH director Jeffrey Shuren and calls for his resignation over hi...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a consulting firms assessment of the Prescription Drug User Fee Act Workload Adjust...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on in vitro methods used to assess bioequivalence of nonsystemically absor...[ Price : $8.95]
Federal Register Notice: FDA releases a draft ICH guidance: M4E(R2): The CTD Efficacy.[ Price : $8.95]
Amicus Therapeutics delays its plans to submit an NDA by the end of the year for migalastat, indicated for treating Fabry disease,...[ 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...