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An FDA study of refuse-to-file (RTF) letters finds that 4% of CDER submissions from 2008 to 2017 were issued an RTF.[ Price : $8.95]
Federal Register notice: FDA seeks public comments on an information collection extension associated with its Guidance for Industr...[ Price : $8.95]
Three SheppardMullins attorneys say a recent FTC settlement in a case involving how app users health data is used is a reminder th...[ Price : $8.95]
CDRHers Timothy Stenzel and Toby Lowe answer questions in a virtual town hall about Covid-19 diagnostic tests.[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension for Certification To Accompany Drug, Biological Prod...[ Price : $8.95]
Federal Register notice: FDA posts a list of six information collections that have been approved by the Office of Management and B...[ Price : $8.95]
Two attorneys say that despite fewer Office of Prescription Drug Promotion enforcement letters in 2020 they expect advertising and...[ Price : $8.95]
FDA gives humanitarian device approval to the Additive Orthopaedics patient-specific talus spacer 3D-printed bone implant, a world...