FDA Spells Out Use of Risk-Benefit Factors in Device Approvals August 31, 2016 FDA explains how these factors play into premarket approval or de novo classification. Read More
Cardiovascular Trials Down, Study Finds; Califf Outlines FDA Stance August 31, 2016 Cardiovascular trials declined across Phase 1, 2 and 3 studies. Read More
Assay Importer Lands FDA Warning Over Supplier Controls, Complaints August 30, 2016 The FDA says Tosoh Bioscience failed to properly manage its suppliers and complaints. Read More
Cynapsus Therapeutics Nabs FDA Fast Track for Parkinson’s Disease Candidate August 30, 2016 The candidate is maintenance therapy that treats Parkinson’s symptoms when a standard treatment wears off. Read More
FDA Asks Manufacturers of Syringe Pumps to Revise Labels, Warnings August 29, 2016 The revisions would address flow continuity deficiencies that the FDA identified. Read More
FDA Recommends Bioequivalence Studies for Fidaxomicin Generics August 29, 2016 One study that FDA recommends is an in vivo study with clinical endpoints. Read More
NICE Gives Nod to HeartFlow’s Cardiac Imaging Platform August 26, 2016 The device is intended for patients with onset chest pain of cardiac origin and a risk for coronary artery disease. Read More
U.S. Patent Office Rejects Two Teva Patents for MS Drug Copaxone August 26, 2016 The two patents covered a 40 milligram injection of Copaxone. Read More
FDA Approves Post-Concussion Testing Devices August 25, 2016 The two devices are the first to be indicated for cognitive assessment after a concussion. Read More
FDA Clarifies Rationale for Refusing ANDAs for New Drug Strengths August 25, 2016 Insufficient justifications for impurities in products prompt FDA refusals. Read More
Regeneron Nabs HHS Funding for MERS Therapies August 24, 2016 Regeneron will receive up to $8.9 million to cover drug development costs. Read More
Amedica Earns FDA Clearance for Expanded Sizes of Valeo II Lateral Lumbar Device August 24, 2016 The expanded sizes are intended to accommodate a broader range of patient anatomies. Read More