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TXT Spectral Medical Filing Last PMA Module for Sepsis Device [95 Words] [ Price : $8.95]
Spectral Medical says it plans to submit in the second quarter the last of four modules for a PMA for Toraymyxin, indicated for treating patients with endotoxemic septic shock.
02/23/2017
 
 
TXT FDA’s Gene Therapy Regulatory Role [2729 Words] [ Price : $8.95]
A new National Academies book on the science, ethics, and governance of human genome editing looks at the role FDA plays as one of several bodies involved in regulating and oversight in this discipline.
02/23/2017
 
 
TXT Academics Promote Expensive Drugs for Companies [2834 Words] [ Price : $8.95]
ProPublica takes a lengthy look at “academics-for-hire” who help drug companies justify high drug prices through Precision Health Economics, a consulting firm.
02/23/2017
 
 
TXT Over-, Under-reaction in Device Recall Decisions: Study [2830 Words] [ Price : $8.95]
Researchers say that medical device company decision makers often over- or under-react to adverse event reports when considering device recalls.
02/22/2017
 
 
TXT FDA Rejects Amphastar NDA for Nasal Naloxone [103 Words] [ Price : $8.95]
FDA issues Amphastar Pharmaceuticals a complete response letter on an NDA for naloxone hydrochloride 2mg/0.5mL nasal spray, indicated for the emergency treatment of known or suspected opioid overdose.
02/22/2017
 
 
TXT FDA Accepts Ocular Therapeutix NDA Resubmission [199 Words] [ Price : $8.95]
FDA accepts an Ocular Therapeutix NDA resubmission for Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use for treating ocular pain occurring after ophthalmic surgery.
02/22/2017
 
 
TXT Praise for ICH Addendum [2656 Words] [ Price : $8.95]
PhRMA says an International Council on Harmonization revision of an addendum on clinical investigation of medicinal products in pediatric patients is a welcome change that addresses the many advances that have occurred since the original was promulgated.
02/22/2017
 
 
TXT Panel to Consider Claret Medical Sentinel System [2695 Words] [ Price : $8.95]
FDA reviewers ask the Circulatory System Devices Panel to comment on the benefit-to-risk ratio of using the Claret Sentinel cerebral protection system during TAVR procedures.
02/22/2017
 
 
TXT Trump Focused on Health Policy Changes: Ubl [2695 Words] [ Price : $8.95]
PhRMA president Stephen Ubl says the Trump administration is looking at ways to retain U.S. leadership in drug development and promote innovation in medicine.
02/22/2017
 
 
TXT Former CDRH Official Spyker Joins NDA Partners [127 Words] [ Price : $8.95]
Former CDRH Division of Cardiovascular, Respiratory, and Neurological Devices acting deputy director Daniel Spyker joins NDA Partners as an expert consultant.
02/22/2017
 
 
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