Federal Register notice: As part of FDAs ongoing Drug Efficacy Study Implementation, the agency announces that all outstanding hearing requests regard...
Student advocates from Universities Allied for Essential Medicines ask to meet with FDA commissioner Robert Califf on ways to improve clinical trial r...
Medtronic recalls its Harmony Delivery Catheter due to the potential for a break in the bond holding the capsule at the end of the delivery catheter.
Former FDA principal deputy commissioner Joshua Sharfstein says Congress and FDA must continue to look at whether the McKinsey consulting firm abused ...
The Department of Justice subpoenas Philips Respironics and certain other Philips subsidiaries in the U.S. for information on the events that led to t...
Federal Register notice: FDA sends to OMB an information collection extension entitled Export Notification and Recordkeeping Requirements.
Federal Register notice: FDA classifies the autofluorescence detection device for general surgery and dermatological use into Class 2 (special control...
FDA issues a four-item Form FDA-483 to Wedgewood Connect after an inspection of its San Jose, CA drug manufacturing facility cited significant GMP vio...