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Hearing on Fecal Microbiota for Transplantation

[ Price : $8.95]

Federal Register notice: FDA announces an 11/4 public hearing to obtain input on the use of fecal microbiota for transplantation t...

Treatment Effect Influences FDA Approval Decisions: Study

[ Price : $8.95]

Researchers say they could not find a clear threshold of magnitude of treatment effect that would lead FDA to not request randomiz...

Regulatory Review Period for Edwards Aortic Bioprosthesis

[ Price : $8.95]

Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Edwards Lifesciences Perica...

EMD Serono Gains Breakthrough for Lung Cancer Drug

[ Price : $8.95]

FDA grants EMD Serono a breakthrough therapy designation for its investigational targeted therapy tepotinib in certain patients wi...

Modeling Tool for Coronary Artery Disease Cleared

[ Price : $8.95]

FDA clears a HeartFlow 510(k) for the HeartFlow Planner, a real-time virtual modeling tool for coronary artery disease interventio...

Advisory Panel to Discuss Vascepa sNDA

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Federal Register notice: FDA announces an 11/14 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss an Amarin...

Bloomberg Businessweek Reviews Valsartan Contamination

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Bloomberg Businessweek takes a lengthy review of the FDA involvement in the case of contaminated valsartan and other hypertension ...

Patent Abuse Leads to Higher Drug Prices: Column

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A CNN opinion column calls for patent reform as a means of helping to address high drug prices.

Class 1 Assigned to Allergan Breast Implant Recall

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FDA classifies as Class 1 an Allergan July recall of its Biocell textured breast implant products.

Advisors to Consider Peanut Allergy Treatment

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FDA asks the Allergenic Products Advisory Committee to comment on whether efficacy and safety data support approval of Aimmune The...