ICH Addresses API Makers’ Concerns With Q7 Q&A Guide June 26, 2015 The guidance clarifies requirements for quality management, documentation, equipment cleaning and more. Read More
SentreHeart Secures FDA Approval for Amaze Trial June 25, 2015 The study is evaluating the Lariat suture delivery system’s ability to provide closure of the left atrial appendage. Read More
FDA Grants Peanut Allergy Drug Breakthrough Status June 25, 2015 AR101 is an oral immunotherapy meant for children and adolescents with peanut allergies. Read More
Advanced Cooling Therapy Snags FDA De Novo Clearance for Esophageal Cooling Device June 24, 2015 The product is the only temperature modulation device to use the esophageal space to cool or warm patients, company claims. Read More
FDA and EMA Strive for Convergence on Path to Harmonization June 24, 2015 The agencies want to standardize their respective pharmacovigilance and quality by design programs. Read More
Boston Scientific Initiates Emblem System Trial June 23, 2015 The subcutaneous implantable defibrillator is designed to prevent sudden cardiac death in patients with severely reduced cardiac function. Read More
Allergan Bolsters Facial Aesthetics Portfolio With Kythera Acquisition June 23, 2015 The deal is valued at $2.1 billion. Read More
Zimmer Recalls Hip Prosthesis Over Residue June 22, 2015 Prostheses were manufactured between March 31 and April 20, 2015, the Class I recall notice says. Read More
FDA Updates Salt Drug Naming Guidance June 22, 2015 The agency formally adopted the U.S. Pharmacopeia’s strict naming rules for drug containing salt-based active ingredients. Read More
Terumo Launches Self-Expanding Stent in U.S. June 19, 2015 The peripheral artery disease treatment gained FDA approval in May. Read More
EU to Release New Guideline on Risk Management Plans June 19, 2015 The updated Module V will align risk definitions with the International Conference on Harmonisation. Read More
Sapien 3 Artificial Heart Valve Nabs FDA Nod June 18, 2015 The third generation product features a skirt at the base of the valve meant to minimize leakage around the device. Read More