FDA Committee Unanimously Recommends New Subcutaneous Dose of Rituxan April 4, 2017 The committee voted 11-to-zero that Rituxan SC had a favorable risk-benefit profile. Read More
FDA Reports to Congress on Regulatory Science Achievements April 4, 2017 CDRH researchers developed computational tools to support nonclinical evaluation of medical products. Read More
Gottlieb to Recuse Himself from Agency Decisions on More than 20 Companies April 3, 2017 Gottlieb plans to resign from 13 industry roles. Read More
McCaskill Requests Documents, Sales Pitches from Five Top Opioid Manufacturers April 3, 2017 Company CEOs Depomed received letters from McCaskill requesting internal estimates from the past five years. Read More
FDA Clears QIAGEN JAK2 Assay March 31, 2017 The JAK2 assay is the first and only FDA-cleared kit for the JAK2 V617F mutation. Read More
FDA Places Divi’s Facility on Import Alert March 31, 2017 The facility’s R&D division also fell short on GMP requirements. Read More
FDA Awards Marketing Clearance to Bodycad’s Personalized Unicompartmental Knee System March 30, 2017 The device is designed to the patient's anatomical features and kinematics. Read More
EMA Recommends EU Approval for Six Drugs, Including Three Orphan Drugs March 30, 2017 CHMP recommended the drug conditionally that the company would commit to post-authorization obligations and monitoring. Read More
FDA Clears Providence Medical Technology’s Cervical Cage-L System and Facet Screws March 29, 2017 The devices are used for cervical fusion. Read More
MHRA Lists Most Common Errors in Clinical Trial Applications March 29, 2017 Sponsors must also include all potential risks to trial participants. Read More
FDA Expert Panel Seeks Solutions for Peroxide Contact Lens Risks March 28, 2017 Panelists said warning labels and instructions for use should be simpler and more consistent. Read More
GAO to Investigate the FDA’s Approval Process for Orphan Drugs March 28, 2017 The lawmakers requested a comprehensive list of orphan drugs approved since 1983. Read More