About this blog

CRIT is no longer adding posts or updating the CRITical Thinking blog.

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research.

This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.

 

Tags

patient advocacy
trial reporting
CCI
regulatory approval
market exclusivity
data sharing
Pharmaceutical Marketing
FDA
medical evidence
transparency
meta-research
EMA
payers
right to try
lifecycle evaluation
research integrity
reproducibility
trials
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CRITical Thinking Blog

Federal Judge Rules in FDA's Favor in Dispute Over Pediatric Exclusivity: A Win for the Agency, Patients, and Clinical Evidence

February 21, 2018
By Jeanie Kim, Amy Kapczynski, Joseph S. Ross

On February 17, 2018, a federal judge in the D.C. District Court affirmed the U.S. Food and Drug Administration's decision to deny a six-month extension of market exclusivity for Amgen's blockbuster drug cinacalcet (Sensipar).

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What Would a Pro-Patient, Pro-Public Health Regulatory System Look Like?

February 13, 2018
By Els Torreele

While we get many new products we don't need, major public health needs remain unmet.

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Seven Thoughts on the History and Present Practices of the FDA and Uses of Prescription Drugs

January 31, 2018
By Donald W. Light, Joel Lexchin

From before 1906, when the Pure Food and Drugs Act was passed, through the Vioxx crisis in 2004 to today, organized pharmaceutical lobbying has consistently tried to undermine Congressional efforts to protect patients from unsafe and ineffective drugs, often with considerable success.

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Regulating Medical Products in the Interest of the Public

October 25, 2017
By Alain Alsalhani

There seems to be a deep confidence crisis in the US Food and Drug Administration (FDA) as an institution.

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