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TXT Foreign Data Integrity Violations Up: Analysis [283 Words] [ Price : $8.95]
A PricewaterhouseCoopers Health Research Institute analysis finds that FDA is issuing an increasing number of warnings for data integrity violations, almost all to companies based outside the U.S.
03/29/2016
 
 
TXT Courts Differ on Drug Patent Litigation Stays [250 Words] [ Price : $8.95]
Two WilmerHale attorneys say a provision of the America Invents Act is causing increased requests for litigation stays in drug patent disputes.
03/29/2016
 
 
TXT NIH Xtandi Cost Hearing Sought [295 Words] [ Price : $8.95]
Twelve members of Congress ask NIH for a public hearing on the price being charged by Astellas for its prostate cancer drug Xtandi.
03/29/2016
 
 
TXT Extend Drug Review Gains to More Areas: CLSA [211 Words] [ Price : $8.95]
The California Life Sciences Association says that FDA and stakeholders should use the next user fee reauthorization to extend faster drug review times to therapeutic areas that have lagged behind.
03/29/2016
 
 
TXT Pediatric Studies on Lorazepam Available [65 Words] [ Price : $8.95]
Federal Register Notice: FDA establishes a docket to make available a report of the pediatric studies of lorazepam.
03/29/2016
 
 
TXT CGMP, Other Violations at Leiter’s Compounding [488 Words] [ Price : $8.95]
FDA’s San Francisco District Office warns Leiter’s Compounding about CGMP and other violations in its work as a compounding drug outsourcing facility.
03/29/2016
 
 
TXT FDA Safety Alert on OxySure Portable Oxygen Device [215 Words] [ Price : $8.95]
FDA says a 6/2015 recall by OxySure Therapeutics involving its OxySure replacement cartridges for the OxySure Portable Emergency Oxygen System Model 615 was ineffective and recommends against their use.
03/29/2016
 
 
TXT CDRH Adds 4 UDI Modules to e-Learning Site [129 Words] [ Price : $8.95]
CDRH adds four new learning modules on unique device identifiers to its online learning catalog “CDRH Learn.”
03/29/2016
 
 
TXT Pediatric Studies on Lorazepam Available [65 Words] [ Price : $8.95]
Federal Register Notice: FDA establishes a docket to make available a report of the pediatric studies of lorazepam.
03/29/2016
 
 
TXT FDA Issues Newron Pharma Complete Response on Safinamide [87 Words] [ Price : $8.95]
FDA issues Newron Pharmaceuticals a complete response letter on an NDA for safinamide, indicated for treating patients with Parkinson’s disease.
03/29/2016
 
 
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