Tag Archives: severe sepsis

The New Default: 1 (One) Single Pivotal Trial

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Statements that have the words ‘FDA’ and ‘flexibility’ in a single sentence need to be approached with some skepticism.  Especially if made by the Agency. ‘Flexibility’ always sounds better than ‘less rigidity’. Regulators are tasked with providing a certain sense of consistency or stability in the drug development jungle where Continue reading The New Default: 1 (One) Single Pivotal Trial→

Recent Sepsis Literature

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SIRS, sepsis, severe sepsis, septic shock is a continuum, a crescendo of signs and symptoms associated with an infection uncontrolled by host responses. An avalanche or cascade of seemingly unstoppable events occurs often in a matter of hours which has defied causal intervention but for which symptomatic treatment has improved Continue reading Recent Sepsis Literature→