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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

[ Price : $8.95]

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

Bloomberg Businessweek Reviews Valsartan Contamination

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Advisors to Consider Peanut Allergy Treatment

[ Price : $8.95]

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

Calcimar Not Withdraw Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Sanofi Aventis Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn fr...

Aegea Vapor System Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Tsunami MedTechs Aegea Vapo...

Suggestions for Use Instructions Guidance

[ Price : $8.95]

Four stakeholders suggest changes to an FDA draft guidance on the format and content of instructions for use information for drugs...

Comments Sought on 21 Substances for Drug Scheduling

[ Price : $8.95]

Federal Register notice: FDA requests comments on 21 drug substances concerning abuse potential, actual abuse, medical usefulness,...