Webinar: Cures Act Leaves Combination Product Issues Unresolved April 20, 2017 In almost every case, a combination product involving a chemical action is automatically referred to CDER. Read More
EMA Publishes Draft Guideline on Complying with Clinical Trial Master File Requirements April 20, 2017 Regardless of paper or electronic formats, trial master file information should be verifiable with an audit trail. Read More
Life Spine Gains FDA Clearance of Plateau-C Ti Cervical Spacer System April 19, 2017 The device offers additional graft windows for increased visibility in-situ and bone graft containment. Read More
FDA Hits Guardian Drug for Lack of Quality Controls, Secure Data April 19, 2017 The agency faulted the facility’s lack of appropriate controls for laboratory reagents and reference standards. Read More
IMDRF Issues Final Guidance on Adverse Event Reporting Terms April 18, 2017 The sets of terminologies are intended for use by reporters of AEs. Read More
GSK Seeks Supreme Court Ruling on Paxil Suit Jurisdiction April 18, 2017 Paxil’s research program spanned 44 states and nine countries. Read More
FDA Warns Abbott Over Defibrillator Manufacturing Issues April 17, 2017 The agency says Abbott shipped 10 implantable cardiac defibrillators from one of its distribution centers despite a recall. Read More
PhRMA Backs FDA Plan to Improve Distribution of Inspection Information April 17, 2017 Nearly 88 percent of reviews missed the deadline. Read More
Minerva Surgical Claims Patent Infringement Against Hologic April 14, 2017 Minerva hopes to block U.S. sales of Hologic’s endometrial ablation system. Read More
FDA Hits Aurobindo for Computer Controls, Documentation Issues April 14, 2017 The facility lacked written procedures to avoid contamination of sterile drug products. Read More
Health Canada Approves Sight Sciences Viscosurgical System April 13, 2017 This single-use device provides a 360-degree canal procedure. Read More
PhRMA Backs FDA Plan to Improve Distribution of Inspection Information April 13, 2017 Nearly 88 percent of the reviews missed the deadline due to late completion of GMP inspections. Read More