FDA Awards Marketing Clearance to Mazor Robotics’ Spinal Deformity Correction Planning Software April 12, 2017 Mazor X is an extension to the company’s proprietary pre-operative analytics software. Read More
FDA Hits Aurobindo for Computer Controls, Documentation Issues April 12, 2017 Inspectors noted the facility lacked appropriate controls for computer systems. Read More
REVA Receives CE Mark for Its Bioresorbable Coronary Scaffold April 11, 2017 This device is an alternative to metal stents to treat coronary artery disease. Read More
In a Joint Meeting, Advisory Committees Recommend Approval of Abuse-Deterrent Opioid April 11, 2017 Opioid abuse will be one of Gottlieb’s top priorities if confirmed. Read More
FDA Approved Expanded Indication of Marketing Clearance for Verax PGD Test April 10, 2017 The device is FDA cleared as a safety measure for bacterial contamination in platelets. Read More
FDA Cites Emcure for Validation, Testing and Reporting Issues April 10, 2017 The facility lacked adequate validation of its cleaning procedures. Read More
Intralytix Receives FDA Clearance for Phage-Based Shigella Technology April 7, 2017 The company already has three approved phage-based products on the market. Read More
FDA Agrees to Abridged Phase III Trial for Wockhardt Antibiotic April 7, 2017 WCK 5222 is a combination of cefepime and zidebactam, a new drug developed by Wockhardt. Read More
FDA to Begin ORA Reorganization in Mid-May April 6, 2017 The current five-region structure will be replaced with six program areas. Read More
ANDA Applications Could Hit New Record in Fiscal 2017 April 6, 2017 Fiscal 2016 saw 852 applications total, while December 2016 alone brought in 235. Read More
Proposal Would Combine FDA Regs for IVDs, Lab-Developed Tests April 5, 2017 The FDA regulates IVDs but does not actively regulate LDTs. Read More
Industry Orgs Urge FDA to Delay New Quality Metrics Program April 5, 2017 Six organizations signed a joint letter saying the burden of the metrics collection outweighs the benefits. Read More