An FDA study of refuse-to-file (RTF) letters finds that 4% of CDER submissions from 2008 to 2017 were issued an RTF.
Federal Register notice: FDA sends to OMB an information collection extension for Certification To Accompany Drug, Biological Product, and Device Appl...
Federal Register notice: FDA posts a list of six information collections that have been approved by the Office of Management and Budget.
Two attorneys say that despite fewer Office of Prescription Drug Promotion enforcement letters in 2020 they expect advertising and promotion enforceme...
FDA gives humanitarian device approval to the Additive Orthopaedics patient-specific talus spacer 3D-printed bone implant, a world first.
Two stakeholders comment on an FDA draft guidance on electromagnetic compatibility testing of medical devices.
Federal Register notice: FDA sends to OMB an information collection extension for Expedited Programs for Serious Conditions Drugs and Biologics.
FDA approves expanded MRI labeling for Medtronics InterStim II and InterStim Micro sacral neuromodulation systems that use SureScan MRI leads.