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TXT FDA Data Submission Issues Listed [211 Words] [ Price : $8.95]
Pinnacle21 lists six of the most common data issues in FDA submissions.
11/20/2014
 
 
TXT Stericycle Sees Medical Device Recall Challenges [430 Words] [ Price : $8.95]
Stericycle says its analysis of Q3 medical device recalls identifies a number of contributing factors industry needs to be aware of.
11/20/2014
 
 
TXT Court Denies Ranbaxy Generic Competition Block Bid [260 Words] [ Price : $8.95]
A Minnesota federal judge denies Ranbaxy’s request for a restraining order to stop two generic drug companies from launching generic forms of Nexium and Valcyte.
11/20/2014
 
 
TXT FDA Approves Purdue’s Hysingla [388 Words] [ Price : $8.95]
FDA approves Purdue’s Hysingla ER abuse-deterrent opioid analgesic.
11/20/2014
 
 
TXT Alternative Approach to Drug Name Reservation Proposed [415 Words] [ Price : $8.95]
Novartis proposes an alternate approach to enabling drug companies to reserve proprietary product names.
11/20/2014
 
 
TXT Look at Underlying Trends in Generic Drug Prices: Gottlieb [624 Words] [ Price : $8.95]
Former FDA deputy commissioner Scott Gottlieb calls on Congress to focus on underlying policies and trends that could lead to an overall increase in generic drug prices.
11/20/2014
 
 
TXT FDA, EMA Advance ‘Mutual Reliance’ on GMP Inspections [209 Words] [ Price : $8.95]
FDA meets with European Medicines Agency and GMP experts from EU member states to advance a “mutual reliance” initiative for GMP inspections.
11/20/2014
 
 
TXT FDA Approves Kubtec Portable X-ray System for Neonates [95 Words] [ Price : $8.95]
FDA approves a Kubtec PMA for its KUB 250, a portable low-dose digital X-ray system dedicated to the neonatal intensive care unit.
11/20/2014
 
 
TXT FDA Grants Fast Track for Novavax for RSV F-Protein Vaccine [141 Words] [ Price : $8.95]
FDA grants Novavax fast track status for its RSV F-Protein nanoparticle vaccine candidate.
11/20/2014
 
 
TXT Groups Back FDA Drug Compounding Enforcement [364 Words] [ Price : $8.95]
Six stakeholder groups praise FDA’s risk-based approach to regulating drug compounding.
11/20/2014
 
 
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