Quest Diagnostics Launches New Digital Dementia Assessment August 4, 2016 This digital assessment tool will aid physicians in assessing individuals with cognitive dysfunction. Read More
EMA Revises “Pandemic Preparedness” Pathway for Flu Vaccine Development August 4, 2016 This pathway will consist of emergent virus strains from animals that can spread to people. Read More
Edwards’ Heart Valve Gain Canadian Approval August 3, 2016 Product is approved for use in patients with symptomatic aortic stenosis. Read More
MHRA Emphasizes Data Integrity Through Pharmaceutical Lifecycle August 3, 2016 Draft guidance shows how data integrity principles apply to GxP. Read More
UDI Guidance Covers Testing, Other Considerations August 2, 2016 Guidance seeks UDIs in two forms on product labels and packages. Read More
BsUFA Fees to Surge for Fiscal 2017 August 2, 2016 BLA filings fees will increase starting Oct. 1. Read More
FDA Weighs How to Apply Real-World Evidence to Regulatory Calls August 1, 2016 Real-world evidence could prove sufficient for regulatory decisions. Read More
EMA Lays out Usage Guidelines for Analyzing Antimicrobials August 1, 2016 Document explains how drugmakers can use microbiological data for dosage determination. Read More
FDA Hosts NGS Webinars July 29, 2016 The draft guidances are part of President Obama’s Precision Medicine Initiative. Read More
Tokai Ends Cancer Trial After Phase 3 Shows Meager Results July 29, 2016 The company concluded that the trial is unlikely to meet its primary endpoint. Read More
Essential Medicine Obtains CE Mark July 28, 2016 Vascular closure device improves access site management. Read More
EMA Suspends 136 Drugs Over Flawed Bioequivalence Studies July 28, 2016 WHO found data integrity issues and sample manipulation at facility. Read More