TGA Investigates Heater-Cooler Devices May 24, 2017 Some heater-cooler devices have been withdrawn from the Australian market. Read More
EMA Updates Guidance for Sponsors Seeking Postmarket Scientific Advice May 24, 2017 The agency’s advice can support proactive pharmacovigilance planning and help develop a well-defined procedural timetable. Read More
EMED Technologies Wins Expanded Indication for Syringe Infusion System May 23, 2017 The device administers human plasma-derived immunoglobulin biologics. Read More
Eleven Senate Democrats Warn Proposed Cuts Would Hurt Cures Act Implementation May 23, 2017 Trump’s budget blueprint for the next fiscal year seeks deep cuts to federal agencies. Read More
Device Firms Issue Advisories Following Ransomware Attack May 22, 2017 Siemens said it is developing patches for medical devices that may have been affected. Read More
Lawmakers Call for White House Action, User Fee Legislation to Lower Drug Prices May 22, 2017 Senators called for the White House and HHS to certify the importation of medicines from Canada. Read More
Ophtec Wins CE Mark for Precizon Presbyopic May 19, 2017 The misalignment tolerance reduces photic phenomena to assist patients in adapting to their vision. Read More
Celltrion Files Two Additional Petitions for PTO Review of Genentech’s Herceptin Patents May 19, 2017 The South Korean biosimilars manufacturer recently challenged four Genentech patents. Read More
CE Mark Suspended on GI Dynamics’ EndoBarrier May 18, 2017 All implanted patients may continue treatment. Read More
House E&C Committee Pulls Distributors, DEA into Opioid Epidemic Investigation May 18, 2017 The representatives cited a single pharmacy in a town of 392 residents that received nearly nine million hydrocodone pills over two years. Read More
CrossBay Medical Nabs FDA Clearance and CE Mark for IVF Embryo Transfer Catheter Set May 17, 2017 The device is guided by ultrasound. Read More
Health Canada Proposes Updates to Drug Pricing Framework May 17, 2017 Canada to update drug pricing regulations after 20 years. Read More