Daily Archives: June 23, 2008

Approvable Letter Issued to Eurand

Eurand Pharmaceuticals announced last week that the company had received an approvable letter from the FDA for its NDA for EUR-1008 (pancrealipase capsules) for the treatment of exocrine pancreatic insufficiency (EPI).  The company did not state the FDA’s reasoning for … Continue reading

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Hurry Up and Wait – Delaying Priority Reviews

Earlier this year the FDA Director of the Office of New Drugs John Jenkins indicated that the agency would have a decreased ability to meet PDUFA dates, saying that the agency was short-staffed.  Congress has also been investigating the use … Continue reading

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