FDA Grants Abbott Marketing Clearance for Zika Virus Test February 2, 2017 The Abbott real-time Zika test is designed for use on the m2000 real-time system. Read More
EMA Committee Recommends Eight Medicines for Approval February 2, 2017 The products include two Amgen biosimilars. Read More
Abbott Gains FDA Approval for its Assurity MRI Pacemaker February 1, 2017 The devices are not affected by MRI scans. Read More
Pharma Companies, Healthcare Groups Urge Trump to Support Value-Based Care February 1, 2017 The organizations have made significant investments in building alternative payment models. Read More
Medtronic Gains CE Mark for Lower Profile HawkOne 6F Directional Atherectomy System January 31, 2017 The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. Read More
Shredded Documents, Dirty Equipment Net Hetero Labs a Form 483 January 31, 2017 Recording showed extensive shredding of documents. Read More
Covidien Gets Form 483 for Complaint Procedures January 30, 2017 Procedures describing process controls were not adequately established. Read More
EMA: 30 Drugs Granted Conditional Market Authorization in the Past Decade January 30, 2017 The EMA received 52 applications for conditional marketing authorization. Read More
FDA Reclassifies Influenza Test Systems as Class II January 27, 2017 There is evidence that currently available antigen-based RIDTs are performing poorly. Read More
ICH Seeks to Flesh out Guidances on Data Quality, Medication Errors, Product Issues January 27, 2017 The ICH noted that poor quality in the initial data collection could compromise safety evaluations. Read More
Pemco Lands Form 483 For Correction and Removal Actions January 26, 2017 Inspectors found that non-conforming products were not adequately controlled. Read More
New Study Shows Pharma Rebates, Discounts Growing January 26, 2017 The study defines gross expenditures as the sum of all payments for prescription drugs. Read More