Showing posts with label pharma legislation. Show all posts
Showing posts with label pharma legislation. Show all posts
Wednesday, February 22, 2017

Establishing efficacy - without humans?

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The decade following passage of FDAAA has been one of easing standards for drug approvals in the US, most notably with the advent of “break...
1 comment:
Wednesday, July 31, 2013

Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA?

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Results reporting requirements are pretty clear. Maybe critics should re-check their methods? Ben Goldacre has rather famously described t...
8 comments:
Wednesday, August 8, 2012

Testing Transparency with the TEST Act

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A quick update on my last post regarding the enormously controversial -- but completely unmentioned -- requirement to publicly report all v...
Monday, August 6, 2012

Public Protocols? Burying the lede on the TEST Act

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Not to be confused with the Test Act . (via Luminarium) 4 Democratic members of Congress recently co-sponsored the TEST (Trial and Expe...
Tuesday, July 31, 2012

Clouding the Debate on Clinical Trials: Pediatric Edition

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I would like to propose a rule for clinical trial benchmarks. This rule may appear so blindingly obvious that I run the risk of seeming simp...
2 comments:
Friday, July 13, 2012

Friday Flailing: Medical Gasses and the Law of the Excluded Middle

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Buried A ristotle never actually said "principium tertii exclusi" , mostly because he didn't speak Latin. under the mass ...
Thursday, January 12, 2012

Changing the Rules, Ever So Slightly, For Rare Diseases

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At the end of last year, US Reps Cliff Stearns (R-FL) and Ed Towns (D-NY) introduced the Unlocking Lifesaving Treatments for Rare-Diseases A...