Philips Gains FDA Marketing Clearance For Its Next-Generation Of Intellivue Guardian Solution February 21, 2017 The device constantly measures heart rate, respiratory rate, posture and detects falls. Read More
EMA Clarifies Approach to Pharmacovigilance Fees in Revised Q&A Guidance February 21, 2017 The fees apply only to sponsors of nationally authorized drugs. Read More
South Africa Releases Draft Regs For Drug-to-Device Transfers February 17, 2017 Transfer applications must be made by the manufacturer’s authorized representative. Read More
EMA Proposes Clarification to Anti-Cancer Drug Guidance Ambiguities February 17, 2017 The guideline was made available for public comment by both the EMA and the FDA last year. Read More
FDA Dings X-Zeal on Design Validation, Reporting Procedures February 16, 2017 The user manual did not ensure that installation instructions were validated by dentists. Read More
Grassley Plans to Investigate Orphan Designation’s Impact on High Drug Prices February 16, 2017 Orphan Drug Act provisions appear to be “stretched beyond their original intent,” Grassley said. Read More
FlowAid Gets FDA Market Clearance for the FA100 SCCD February 15, 2017 The device increases local blood circulation. Read More
Senators Request Details on Kaléo’s Pricing Model for Overdose Drug Evzio February 15, 2017 The senators ask for the company to explain why it adjusted the list price of the drug. Read More
Savaria Concord Lifts Cited for CAPA Procedures February 14, 2017 Savaria Concord Lifts makes wheelchair lifts, stair lifts, home elevators, and related devices. Read More
Generics Applications Fell by About 76% to 57 Submissions, Lowest in 9 Months February 14, 2017 The submission total recorded last month is the lowest since April. Read More
Biotronik Gets Warning Letter For Validation, Other Procedures February 13, 2017 Biotronik makes catheters, coronary guide wires, implantable pacemakers, and implantable cardioverter defibrillators. Read More
Right-to-Try Legislation Finds Support on Capitol Hill and in the White House February 13, 2017 The law would allow terminally ill patients to use unapproved products that clear Phase I safety testing. Read More