Aviva Lev-Ari, PhD, RN
FDA-related Research and Publications
Minimally Invasive Structural CVD Repairs: FDA grants 510(k) Clearance to Philips’ EchoNavigator – X-ray and 3-D Ultrasound Image Fused.
Curator: Aviva Lev-Ari, PhD, RN
FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology
Curator: Aviva Lev-Ari, PhD, RN
Demonstrate Biosimilarity: New FDA Biosimilar Guidelines
Reporter: Aviva Lev-Ari, PhD, RN
The FDA/CMS Summit For Biopharma Executives 2013: Prepare For Health Reform, December 10 & 11, 2012, WashDC
Reporter: Aviva Lev-Ari, PhD, RN
Xarelto (Rivaroxaban): Anticoagulant Therapy gains FDA New Indications and Risk Reduction for: (DVT) and (PE), while in use for Atrial fibrillation increase in Gastrointestinal (GI) Bleeding Reported
Reporter: Aviva Lev-Ari, PhD, RN
FDA Approval for Under-Skin Defibrillator goes to Boston Scientific Corporation
Reporter: Aviva Lev-Ari, PhD, RN
FDA: Strengthening Our National System for Medical Device Post-market Surveillance
Reporter: Aviva Lev-Ari, PhD, RN
Not Having 510(k) Clearance, FDA advised Recall of Stryker’s Neptune following recall of pair of metal hip implants
Reporter; Aviva Lev-Ari, PhD, RN
23andMe Takes First Step Toward FDA Clearance
Reporter: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2012/08/01/23andme-takes-first-step-toward-fda-clearance/
Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice
Reporter: Aviva Lev-Ari, PhD, RN
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Curator: Aviva Lev-Ari, PhD, RN
Biosimilars: Financials 2012 vs. 2008
Curator: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2012/07/30/biosimilars-financials-2012-vs-2008/
Biosimilars: CMC Issues and Regulatory Requirements
Curator: Aviva Lev-Ari, PhD, RN
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