European Union Grants CE Mark for Intact Vascular’s Tack Endovascular System January 17, 2017 The device can be used in arteries ranging from 1.5 mm to 4.5 mm in diameter. Read More
WHO Recommends 10 Compounds to be Classified as Internationally Restricted Substances January 17, 2017 Two synthetic opioids are being proposed for the most restricted class of controlled substances. Read More
Final Guidance Addresses Medical Device Cybersecurity Reports January 13, 2017 Companies must report of vulnerabilities within 30 days and eliminate it within 60 days. Read More
EMA Clarifies Exposure Limits, Risk-Based Models for the Prevention of Contamination in Drug Manufacturing January 13, 2017 The guideline supplements a draft document from 2013. Read More
New Zealand Proposes to Use Zimmer Biomet Implants January 12, 2017 Proposed agreement would allow Zimmer Biomet to supply about 12,500 products. Read More
FDA Seeks Verification of ANDA Holder List for GDUFA II Fees January 12, 2017 FDA is required to compile a comprehensive list of approved ANDAs to levy the fees in fiscal 2018. Read More
SonaCare Medical Receives FDA Marketing Clearance for Revised Prostate Tissue Removal Device January 11, 2017 The device includes a tissue change monitoring which quantifies RF signals. Read More
FDA to Examine Consumers, Healthcare Professionals’ Capacity to Spot Deceptive Ads January 11, 2017 Two studies would evaluate how consumers and healthcare professionals respond to targeted advertisements. Read More
Teleflex Receives Marketing Clearance for its Arrow VPS Rhythm Device January 10, 2017 The device assists in placement and confirmation of a catheter tip in the superior vena-cava-cavoatrial junction. Read More
Data Integrity Concerns, Quality Controls Prompt 483 for Specialty Drugmaker January 10, 2017 American Antibiotics failed to limit system access to electronic data. Read More
New Zealand Proposes to List New Hip, Knee Implants January 9, 2017 The proposal would let Stryker New Zealand sell about 3,700 orthopedic joint implants to hospitals. Read More
EU Grants Orphan Designation to ARMO BioSciences Immunotherapy for Pancreatic Cancer January 9, 2017 The candidate received an orphan designation from the FDA as well. Read More