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TXT FDA Sets Review Period for Xience Stent System [81 Words] [ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Abbott Cardiovascular Systems’ Xience Xpedition Everolimus Eluting Coronary Stent System for the purpose of patent extension.
04/29/2015
 
 
TXT FDA Solicits Regulatory Science Research Proposals [301 Words] [ Price : $8.95]
FDA solicits research proposals to support specified aspects of regulatory science.
04/29/2015
 
 
TXT Expedited Agency Review Supported, Criticized [542 Words] [ Price : $8.95]
Stakeholders debate the merits of industry’s Expedited Agency Review proposal for generic drug safety labeling changes.
04/29/2015
 
 
TXT Eshoo Reintroduces American Cures Act [297 Words] [ Price : $8.95]
Rep. Eshoo reintroduces her American Cures Act to increase research funding to federal agencies.
04/29/2015
 
 
TXT Biogen/AbbVie Multiple Sclerosis BLA Accepted for FDA Review [144 Words] [ Price : $8.95]
FDA accepts for review a Biogen and AbbVie BLA for Zinbryta (daclizumab high-yield process) for relapsing forms of multiple sclerosis.
04/29/2015
 
 
TXT Woodcock to Senate: ‘Unfunded’ Mandates Could Hurt Reviews [1086 Words] [ Price : $8.95]
During a Senate hearing on pending legislation to help medical product innovation, CDER director Janet Woodcock warns lawmakers that product review activities could be slowed if the agency is given more duties than it can handle.
04/28/2015
 
 
TXT Rx Prices Continue Upward Move in First Quarter [152 Words] [ Price : $8.95]
Truveris’ National Drug Index reports that prescription drug prices continue to increase, with first quarter prices jumping 3.8%.
04/28/2015
 
 
TXT Senate Bill Would Cut FDA Mobile App ‘Red Tape’ [312 Words] [ Price : $8.95]
Sens. Bennett and Hatch reintroduce legislation to limit and clarify FDA’s role regulating some mobile apps and software.
04/28/2015
 
 
TXT CDER Plans 98 New, Revised Guidances in 2015 [194 Words] [ Price : $8.95]
FDA releases its 2015 Guidance Agenda calling for 98 new and revised guidances to be published this year.
04/28/2015
 
 
TXT Environmental Assessment Draft Guidance Out [240 Words] [ Price : $8.95]
FDA issues a draft guidance addressing environmental assessment of drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity in environmental organisms.
04/28/2015
 
 
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