Training (finally) for reviewers at the CDRH (Weekend Rounds)

A review of life science current events reported by MedCity News this week: Shuren to […]

A review of life science current events reported by MedCity News this week:

Shuren to MN device industry: Reviewers will undergo training. One long-running complaint, among the litany of complaints, about the U.S. Food and Drug Administration revolves around reviewers at the Center for Devices and Radiological Health. Dr. Jeffrey Shuren, director of CDRH, admitted that at least some of the criticism is legitimate and outlined some changes to how the reviewers will function in the future.

FDA, Minnesota device industry to collaborate on regulatory science. How can there be speedy, early assessments of new innovative medical devices? The U.S. Food and Drug Administration and the Minnesota medical device community may have hit upon an answer. At the close of a two-day visit to Minnesota Tuesday by Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, and some CDRH staff, a Minnesota trade group announced that a newpublic-private partnership will be formed focusing on regulatory science.

Neoprobe: Hedge fund manager calls off short sale recommendation. Figuring Neoprobe’s stock price has fallen far enough, the hedge fund manager who drew attention for criticizing the company has called off his recommendation to short its shares.

The Dendreon-Provenge Effect: Innocent biotech stocks tumble. When one biotech company sneezes, the others catch the cold. Right now, industry eyes are on sickly Dendreon (NASDAQ:DNDN), the Seattle biotech that released second quarter financial results that saw sales of prostate cancer treatment Provenge fall spectacularly short of expectations. So The Nasdaq Biotechnology Index, an index of biotechnology and pharmaceutical stocks listed on the Nasdaq, was down 6.2 percent.

Whether it’s media or medical industry, Kool-Aid is a killer. We’re in a world that’s short on jobs, short on tax revenue, short on investor capital, short on opportunity and, I would argue, even short on hope. If someone with credibility appears waving dollar signs or selling the perfect entrepreneurial dream, it’s easy to drink the Kool-Aid by the gallons and support something endlessly even when facts on the ground screech, “get a grip!” Resisting that urge as both an entrepreneur and as a journalist is crucial.

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