Medtronic Announces Health Canada Approval for Drug-Coated Balloon February 10, 2017 The device leaves behind medication designed to help prevent the artery from narrowing. Read More
Spanish Antitrust Authority Investigates Prices of Aspen Pharma’s Cancer Drugs February 10, 2017 In October 2016, Italy fined Aspen for raising the price of four drugs. Read More
Protech Professional Criticized for Design Control Procedures February 9, 2017 The observation repeated a deficiency cited in a previous warning letter. Read More
FDA to Post Unredacted Advisory Committee CVs, Following Public Citizen Lawsuit February 9, 2017 Nominees will have to consent to the publication of their CV. Read More
UK’s NICE Recommends Sinus Dilation System February 8, 2017 The system uses using balloon dilation to open narrowed or obstructed sinuses. Read More
EMA Publishes Clinical Data from Withdrawn Application February 8, 2017 Mylan recently withdrew its application for aripiprazole. Read More
FDA Clears Inova Diagnotics’ Assays February 7, 2017 The device kits are reagents for the detection of anti-neutrophil cytoplasmic antibodies. Read More
Takeda to Maintain Drug Pricing Model Despite Trump Pressure February 7, 2017 The company earns about 30 percent of its drug revenue from the U.S. Read More
New Zealand Proposes to Use Smith and Nephew Implants February 6, 2017 The proposal would allow Smith and Nephew to supply the products at negotiated prices. Read More
House Reps Ask Trump to Clarify FDA’s Status Under Hiring Freeze February 6, 2017 The letter requested a detailed description of the agency positions that would be exempt from the freeze. Read More
MTI Precision Products Gets Form 483 for Design Change February 3, 2017 The procedures for design change were inadequate. Read More
Senators Ask if FDA Will Fill Reviewer Vacancies Despite Hiring Freeze February 3, 2017 The authors asked whether the agency would exempt any job positions. Read More