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Janet Woodcock

Janet Woodcock, FDA and Sasisekharen Cleared of Conflict of Interest


Had been checking for updates on this for so long that I missed last week's closure

From 'On Pharma'

Science in Action at FDA: A Belated Look at the 2008 Science Writers' Symposium


Last year, I attended FDA’s first science writers’ symposium, an interesting program that I’m looking forward to again this year. I wrote up a brief report on the event and took some very amateur videos of scientists’ presentations, envisioning the construction of some grand documentary on FDA's new lab facilities . . . then, my laptop was stolen during a trip, the article was lost and material never made it onto our web site.

From 'On Pharma'

FDA Raked Over the Coals (Again)


January has been another tough month for FDA. There were the whistleblower reports from the Center for Devices, then the Government Accounting Office blasted the Agency for lax review of high-risk medical devices.

From 'On Pharma'

FDA: Dissidents, an Acting Commissioner and Deja Vu All Over Again?


Yesterday brought news that FDA's chief scientist and deputy commissioner Frank Torti would assume the role of acting commissioner within FDA. (More on this from the WSJ blog). Great, he seems uniquely qualified, has a strong scientific background. At the Agency's first science writers symposium last November, he was both responsive and gracious.

From 'On Pharma'

Obama/Biden Policy Highlights STEM Funding; Who Will Advance Science at FDA?


Just saw the Obama/Biden "fact sheet for science" outlining some ambitious goals for the incoming Administration.  Its cornerstones:

From 'On Pharma'

"Heparin Was an Industry Wake-Up Call": A Star Turn by CDER's Janet Woodcock


Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis.  And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W. was reassigned from her post of Chief Medical Officer and Deputy Commissioner to head up CDER.  Using the triage imagery of the Emergency Room, running the Critical Path initiative is important, but maintaining control of CDER, drug review and inspections, is urgent.

From 'On Pharma'