Industry Urges FDA to Impose Stricter Standards on Exemptions for Near Replicas November 2, 2016 Drug companies say outsourcing facilities use loopholes to compound near replicas. Read More
Tyto Care Receives FDA Clearance November 1, 2016 TytoCare’s modular exam tools and telehealth platform enable a remote examination. Read More
Data Integrity Concerns Lead to Warning Letter for Czech Facility November 1, 2016 Investigators reviewed an audit trail from the Empower-2 system that stored 8,906 entries. Read More
FDA Approves IDE for Balloon Angioplasty Clinical Study October 31, 2016 The study is designed to enroll 232 subjects at up to a total of 50 U.S. and international sites. Read More
Industry Wants FDA to Improve Inspection Communication, Integration October 31, 2016 Combined GMP and pre-approval inspections complicate communication with the FDA. Read More
FDA Clears Vitros Automation Solutions from Ortho Clinical Diagnostics October 28, 2016 The device system is now available for purchase in the U.S. Read More
UK Report Proposes New Designation for Accelerated Access to Medicines October 28, 2016 The accelerated pathway focuses on getting approved drugs to market. Read More
BioTrace Medical Achieves FDA Clearance of Temporary Pacing Technology October 27, 2016 BioTrace Medical has received FDA 510(k) clearance for the company’s Tempo Lead. Read More
Companion Diagnostics Guidance Needs Clarity on Product Coverage, Industry Commenters Say October 27, 2016 Nearly 30 drugs and biologics with an IVD companion diagnostic have been approved as of June. Read More
Myriad’s BRACAnalysis CDx Test Identifies Patients Who Would Benefit from Olaparib October 26, 2016 The device was included in the SOLO2 study as a diagnostic with olaparib. Read More
FDA Implements Broad Label Change, Adding Warning for All Testosterone Products October 26, 2016 Prescription testosterone products are only approved by FDA as a hormone replacement therapy. Read More
Pinnacle Spine Group Launches InFill V2 Lateral Interbody Device October 25, 2016 The device features a larger, single graft chamber. Read More