FDA Matters Blog

Archive for the ‘FDA-NIH Relations’ Category

Hot Town, Summer in the City—2010

Sunday, July 11th, 2010

For the news media, the only FDA story this coming week will be the two-day advisory committee meeting reviewing the diabetes drug, Avandia. Based on an earlier article (link below), FDA Matters will be looking at how Dr. Hamburg’s FDA handles the discordant voices coming from within the agency.

Missing from public dialogue is the extraordinary (perhaps unprecedented) number of large, consequential projects that FDA will be working on this summer. Every part of FDA is involved in some initiative that could become a “game-changer” for the agency. (more…)

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Posted in Drug Approval and Access, FDA Accountability and Transparency, FDA Leadership, FDA and Congress, FDA and Industry, FDA-NIH Relations, Follow-on Biologics, Food Issues, Orphan Drugs | No Comments »

FDA Leadership and Challenges: Seven Columns to Re-read for 2010

Sunday, January 3rd, 2010

As a rule, FDA Matters does not cover the day-to-day events at FDA and in Congress. Most readers have multiple sources for news about the agency. I doubt I could do better.

Rather, the goal of this blog is to cover larger themes and provide deeper insights into the world of FDA. I place a premium on exploring FDA’s future, as an observer, commentator and instigator. Here are seven columns about FDA leadership and challenges that will help you to better understand the agency in 2010. (more…)

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Posted in FDA Leadership, FDA and Congress, FDA-NIH Relations, Planning for FDA's Future | No Comments »

FDA Should Stay Out of Health Care Reform

Wednesday, September 30th, 2009

When the new NIH director, Dr. Frances Collins, was interviewed by the New England Journal of Medicine, he stated that one of his priorities is to: “put science to work for health care reform.” I hope that Dr. Hamburg isn’t having similar thoughts about involving FDA in health care reform. (more…)

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Dr. Collins Meet Dr. Hamburg

Tuesday, September 22nd, 2009

FDA and NIH should be working together more closely and productively. For this to occur, Dr. Hamburg and Dr. Collins need to bless a higher level of cross-agency commitment. The critical next step is a publicly announced meeting of the two to develop and advance a common agenda. (more…)

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Dr. Hamburg Meet Dr. Collins

Sunday, July 12th, 2009

FDA and NIH are natural allies, with closely-related purposes as public health agencies. They share a similar worldview that “medical and scientific knowledge derived from random clinical trials” is superior to all other sources. I explored this in an earlier column at: http://www.fdamatters.com/?p=299.

Last week’s announcement of Dr. Francis Collins to be NIH director provides a unique opportunity for FDA. Dr. Hamburg needs to meet Dr. Collins….and create a shared vision. (more…)

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