Monthly Archives: June 2008

FDA Postings on YouTube

Today, the FDA posted a number of videos on YouTube today.    It is worth noting  that the agency is utilizing YouTube to educate patients.  Right now, the FDA has only 61 subscribers and has had a YouTube account since … Continue reading

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New Media and Pharmaceutical Public Affairs

This week, I produced a draft of a paper that overviews the use of new and social media in public affairs.  I was fascinated to find that not only are several members of Congress now twittering, the Clerk of the … Continue reading

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A Guide to the Senate Elections

As we breathe a sigh of relief that the primaries are all finished, and the nominees identified, it is important to take note of the way the character of the election cycle as seen from various perspectives.  It is, after … Continue reading

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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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