UK Issues Alert on Underdosing With Roche’s Accu-Check Insulin Pump August 23, 2016 Cartridges inserted incorrectly can leak insulin. Read More
Pfizer to Purchase Medivation for $14 Billion August 23, 2016 Pfizer inks agreement to acquire Medivation to expand oncology portfolio. Read More
Edwards Transcatheter Heart Valves Approved in Intermediate-Risk Patients August 22, 2016 The FDA lowers the risk level required for use of the heart valves. Read More
UK Warns on Nipro Glucose Strips August 19, 2016 The test strips were not sealed properly when packaged. Read More
Gilead Sciences and Emory Sue Indian Company Over Patent Infringement August 19, 2016 Hetero sent a letter to Gilead saying that their patents would not be infringed. Read More
Citizen Petition Strives for High Standards for Approving Generic Tyvaso August 18, 2016 Drug-device combination must demonstrate efficacy and safety beyond the normal requirements of an ANDA. Read More
TGA Maps Transition to ISO Quality Management Standard August 17, 2016 The agency clarified that the 2003 and 2016 standards will co-exist during the three-year transition period. Read More
EMA Clears Up GMP Standards to Preserve Integrity Across Data Lifecycle August 17, 2016 A Q&A guidance clarifies the risk-based strategies industry can take to safeguard data. Read More
NovaBone Products Obtains GMP Medical Device Certificate August 16, 2016 This certificate extends the distribution of device products for NovaBone. Read More
Sustol Gets FDA Approval for Extended Release August 16, 2016 The drug is approved for use in the prevention of nausea and vomiting related to chemotherapy. Read More
Edwards Lifescience’s Rapid Deployment Valve Receives FDA Approval August 15, 2016 The device was approved based on trial data of 839 patients in the U.S. Read More
Clinical Investigator Gets FDA Warning Letter for Protocol Deviations August 15, 2016 Clinical investigator failed to adhere to an FDA-approved protocol for the trial. Read More