ICH Starts Work on Two Multidisciplinary Drug Development Guidelines October 25, 2016 Current biowaiver policies are not recognized worldwide in all cases. Read More
HeartWare Issues Recall for Ventricular Assist Device Pumps October 24, 2016 The HVAD assists in delivering blood from the heart to the rest of the body. Read More
Equipment Malfunctions, Contamination Issues Nab 483 Citations for Akorn October 24, 2016 The company was cited for several GMP issues. Read More
Vascular Solutions Gains 510(k) Clearance for Fluent Inflation Device October 21, 2016 The design provides a system that is easy to fill, flush, and operate. Read More
GDUFA II Goal: Evaluate 90 Percent of Priority Submissions in Eight Months October 21, 2016 The letter explains the performance goals the FDA has for the next five fiscal years after 2017. Read More
J&J’s Ethicon Releases Harmonic HD 1000i Surgical Shears October 19, 2016 The device has a tapered jaw to enable improved precision access to tissue planes. Read More
Tocagen’s Brain Tumor Treatment Demonstrates Survival of 14 Months in Trial October 19, 2016 Updated data showed that over 20 percent of patients demonstrated an overall response. Read More
FDA Proposes to Create Database of Class II and III Home-Use Device Labels October 18, 2016 Manufacturers often don’t keep instructions on their websites for products they are not actively marketing. Read More
Grassley Hounds DOJ on Whether Mylan Settlement Is ‘Reasonable’ October 18, 2016 Grassley calls on the department to be more transparent about the agreement. Read More
Disease Rarity, Production Limit Added to Custom Device Definition October 17, 2016 The rule states that production of a custom device must be limited to no more than five units per year. Read More
Drug Contained Wrong Ingredient, Company Failed to Test Product, FDA Says October 17, 2016 The FDA collected samples of the company’s drugs at the port of entry. Read More
Vascular Solutions Publishes Class I Recall of Twin-Pass Catheters October 14, 2016 The product was recalled because there is a potential for excess manufacturing material. Read More