Blogs about: Pdufa
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Straight from the horse's mouth: "FDA Science and Mission at Risk"
by Susan F. Wood, PhD It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA. The recently released report (PD… more →
The Pump Handle
RayJay's Saut Pans Stimulus Plan
tristar3research wrote 5 months ago: RayJay’s Jeff Saut deserves credit for being a straight shooter and a smart commentator the ec … more →
US FDA approvals in 2008 totaled 21 new molecular entities (NMEs)
tristar3research wrote 5 months ago: Specialty products continued to dominate new drug and biologic approvals in the US in a year in whic … more →
Comfortably Numb: How Psychiatry Is Medicating a Nation
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esoterickat wrote 1 year ago: I would like to recommend a highly informative book that I read just a few years after giving up TV. … more →
Straight from the horse's mouth: "FDA Science and Mission at Risk"
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sfwskapp wrote 1 year ago: by Susan F. Wood, PhD It’s not often, if ever, that an FDA sponsored report calls out for mor … more →
What you should know about FDAAA 2007!
KHOI wrote 1 year ago: On September 27, 2007, President Bush signed the Food and Drug Administration Amendment Act of 2007 … more →
FDA Advisory Committees: One Person, One Vote
sfwskapp wrote 1 year ago: by Susan F. Wood, PhD FDA recently announced two draft guidances regarding advisory committees, one … more →
Congress's FDA Bill Includes Reforms
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Liz Borkowski wrote 1 year ago: The House and Senate have both passed legislation that renews the FDA’s user-fee system and enacts s … more →
Reducing Conflicts and Increasing Transparency: Why so difficult?
sfwskapp wrote 1 year ago: By Susan F. Wood, PhD Two things appear to be major bones of contention in determining the final v … more →
FDA and Drug Safety - what happened to the IOM report?
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sfwskapp wrote 1 year ago: By Susan F. Wood, PhD In an article in the New England Journal of Medicine today, Sheila Weiss Smi … more →
Women's Health at the FDA - a review of the science
sfwskapp wrote 1 year ago: By Susan F. Wood, PhD The Journal of Women’s Health published a special report and an editorial la … more →
Transparency, strength at the FDA
sfwskapp wrote 1 year ago: The Boston Globe, home town paper of Senator Ted Kennedy, Chair of the Senate Health, Environment, … more →
Friday Blog Roundup
Liz Borkowski wrote 2 years ago: This week, Congress has been wrestling with the reauthorization of the Prescription Drug User Fee Ac … more →
Oh, to be able to make such a difference…
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sfwskapp wrote 2 years ago: By Susan Wood The recent study in the NEJM clearly points out that our drug safety system is in need … more →
Who Supports FDA User Fees?
David Michaels wrote 2 years ago: When you go to the Department of Motor Vehicles and pay your fee to register your car, are you allow … more →
Friday Blog Roundup
Liz Borkowski wrote 2 years ago: The FDA certainly wasn’t the biggest newsmaker this week, but it did create some buzz in the blogosp … more →
FDA legislative action, now with commentary from the New England Journal of Medicine
sfwskapp wrote 2 years ago: By Susan Wood Next week both the Senate and House are moving forward on legislation to reauthorize t … more →
Breaking FDA's User Fee Habit (2)
David Michaels wrote 2 years ago: By David Michaels The Prescription Drug User Fee Act (PDUFA), through which the FDA collects money f … more →
Medarex Stock Options Activity Resembles Dendreon's Trading
247wallst wrote 2 years ago: Stock Tickers: MEDX, DNDN When traders made bets and saw a move of more than 200% at one point onFri … more →
Breaking FDA's User Fee Habit
David Michaels wrote 2 years ago: By David Michaels The campaign by policy experts to have Congress end the user fee system that funds … more →
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