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TXT Gilead Seeks Dismissal of Suit on Alleged FDA Violations [217 Words] [ Price : $8.95]
Gilead Sciences files a motion in Northern California federal court to dismiss a whistleblower-filed False Claims Act lawsuit that alleged FDA regulatory violations and “adulterated” products.
03/23/2015
 
 
TXT Federal Judge Sides with Sandoz and its Biosimilar Product [445 Words] [ Price : $8.95]
A northern California federal judge rejects an Amgen bid to delay Sandoz’s market introduction of the first biosimilar product approved in the U.S. — a copy of Amgen’s Neupogen (filgrastim).
03/20/2015
 
 
TXT Guidance on e-Submissions for BLA Lot Distribution Reports [85 Words] [ Price : $8.95]
FDA posts a guidance on “Electronic Submission of Lot Distribution Reports” that provides information and recommendations on e-submissions of BLA-related lot distribution reports.
03/20/2015
 
 
TXT Antiviral Drugs Panel Terminated [82 Words] [ Price : $8.95]
Federal Register Final rule: FDA terminates the Antiviral Drugs Advisory Committee.
03/20/2015
 
 
TXT FDA OKs Biotronik Eluna Pacemaker System [132 Words] [ Price : $8.95]
FDA approves Biotronik’s ProMRI Eluna pacemaker system to allow patients with both single and dual-chamber Eluna pacemakers to undergo full-body MRI scans.
03/20/2015
 
 
TXT FDA Should Continue DailyMed Use for e-Prescribing Info: Takeda [319 Words] [ Price : $8.95]
Takeda Pharmaceuticals says FDA should consider relying on DailyMed rather than creating a new labels.fda.gov site for electronic distribution of physician prescribing information.
03/20/2015
 
 
TXT Sen. Murray Asks for FDA Info on Duodenoscopes [247 Words] [ Price : $8.95]
Senate Health, Education, Labor, and Pensions Committee ranking member Patty Murray (D-WA) asks FDA for a full review of its practices surrounding duodenoscopes and their association with outbreaks of antibiotic-resistant infections.
03/20/2015
 
 
TXT Panel Recommends Glaxo Asthma Therapy in Adults Only [175 Words] [ Price : $8.95]
A joint meeting of FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee recommends approval for a GlaxoSmithKline supplement NDA for Breo Ellipta (fluticasone furoate and vilanterol) for once daily asthma support in adults.
03/20/2015
 
 
TXT Correction Made on Pediatric Meeting Notice [88 Words] [ Price : $8.95]
Federal Register Notice: FDA corrects a docket number from a 2/26 notice announcing a public meeting seeking pediatric stakeholder recommendations on a report the agency is required to submit on pediatrics.
03/20/2015
 
 
TXT Workshop on E-Cigarettes [77 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Center for Tobacco Products will hold on 6/1-2 the final public workshop in its series of workshops to obtain information about electronic cigarettes and the public health.
03/20/2015
 
 
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