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TXT Pfizer Selling Viagra Online [383 Words] [ Price : $7.95]
Pfizer opens a Web site to sell Viagra directly to consumers holding a valid prescription.
05/08/2013
 
 
TXT FDA Sends Info on Transparency for NMEs to OMB [68 Words] [ Price : $7.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on review transparency for new molecular entity NDAs and BLAs.
05/08/2013
 
 
TXT FDA Debars Freeman [67 Words] [ Price : $7.95]
Federal Register Notice; FDA debars David Freeman for five years from providing services to anyone with an approved or pending drug product application.
05/08/2013
 
 
TXT Meeting on 510(k) Modifications [98 Words] [ Price : $7.95]
Federal Register Notice: FDA plans a public meeting 6/13 on when to submit a 510(k) for a change to an existing device.
05/08/2013
 
 
TXT Amgen Vectibix Trial in Colorectal Cancer Meets Primary Endpoint [141 Words] [ Price : $7.95]
Amgen reports that its Phase 3 ASPECCT trial of Vectibix vs. Erbitux as a single agent for treating chemorefractory metastatic colorectal cancer in patients with wild-type KRAS tumors, met its primary endpoint.
05/08/2013
 
 
TXT Merck BLA for Ragweed Pollen Tablet Accepted for Review [148 Words] [ Price : $7.95]
FDA accepts for review a Merck BLA for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet.
05/08/2013
 
 
TXT Draft Aggregate Reporting Guidance Praised [218 Words] [ Price : $7.95]
Commenters voice support for FDA’s draft guidance on aggregate periodic reporting and ask specific questions for clarification.
05/08/2013
 
 
TXT Hamburg Discusses Sequestration Effects at FDA [238 Words] [ Price : $7.95]
FDA commissioner Margaret Hamburg says she is still worried that sequestration funding cuts will compromise that agency’s regulatory activities.
05/08/2013
 
 
TXT FDA Supporting Antibacterial Drug Development [164 Words] [ Price : $7.95]
FDA’s Antibacterial Drug Development Task Force works with stakeholders through CTTI to improve clinical study quality and efficiency.
05/08/2013
 
 
TXT Maquet Cardio Class 1 Recall on Ventilator Battery Modules [104 Words] [ Price : $7.95]
Maquet Cardiovascular begins a Class 1 recall of the Maquet Getinge Group battery modules for use with the Maquet Servo-i ventilator systems.
05/08/2013
 
 
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