Amy Klobuchar

Devices & Diagnostics

Minnesota senators recruit buddies to pressure FDA over 510(k)

Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program. I doubted the campaign would do much. But Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).

Hospitals

Healthcare reform: The more I know, the less I understand

The healthcare reform law is indisputably an emotionally charged, complicated piece of legislation that can thwart even the best intellects and intentions. Just take LifeScience Alley's seminar on how the law will impact Minnesota's healthcare industry. By my last count, I witnessed an unfortunate analogy, two Freudian slips, and an ill conceived attempt at humor...I think.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

News

Klobuchar, Paulsen urge FDA not to quash Minnesota device industry

Minnesota’s medical device community has enlisted some big guns to lobby the Food and Drug Administration against proposed changes that the industry says will hurt innovation and the state’s economy: United States Sen. Amy Klobuchar and Congressman Erik Paulsen. In a letter to FDA Commissioner Dr. Margaret Hamburg, Klobuchar, chair of the Senate Commerce Subcommittee […]