June 27, 2008
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 →
June 26, 2008
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 →
June 24, 2008
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 →
June 23, 2008
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 →
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 →